Audio Seminars

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Ludwig Huber's Presentations on Validation and Compliance

This site lists presentations developed and delivered by Dr. Ludwig Huber.

Other training material from Ludwig Huber

 

  • July 7, 2016
    Understanding the Final FDA Guidance for Validation of Analytical Methods
    With 10+ best practice guides for easy implementation
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room


  • June 30, 2016
    FDA Compliant IT Infrastructure and Network Qualification

    With Strategies and Tool Kit for Compliance and System Uptime
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar ro
    om

  • Juni 23, 2016
    Integrity of Laboratory Data for FDA/EU Compliance

    Understand and implement data integrity through the entire data life cycle
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • June 15, 2016
    Understanding the new Revision of USP <1058>
    With SOPs, Templates and Examples for easy Implementation
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room


  • June 2, 2016
    Understanding the New FDA Data Integrity Guidance

    With examples and procedures for effective implementation
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar ro
    om

  • April 25/26, 2016, Live Public Seminar, Singapore
    Organized by GlobalCompliancePanel
    Validation and Part 11 Compliance of Computer Systems and Data
    Two-day Workshop
  • April 28/29/, 2016, Live Public Seminar, Mumbai, India
    Organized by GlobalCompliancePanel
    Validation and Part 11 Compliance of Computer Systems and Data
    Two-day Workshop

  • March 3, 2016
    Quality by Design (QbD) for Development and Validation of Analytical Methods

    Comply with FDA Part 11 and EU/PICS Annex 11 for paper, electronic and hybrid records.
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room


  • March 3, 2016
    Ensuring Data Integrity for FDA/EU Compliance

    With focus on conducting risk assessment.
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • February 18/19, 2016, Live Public Seminar, San Francisco, CA
    Organized by ComplianceOnlinel
    Validation, Verification and Transfer of Analytical Methods
    Two-day Workshop

  • February 16/17, 2016, Live Public Seminar, San Francisco, CA
    Organized by ComplianceOnlinel
    Validation and Part 11 Compliance of Computer Systems and Data
    Two-day Workshop

  • January 21 - January 27, Seoul, Bangkog
    Agilent Pharmaceutical Compliance Seminar Series
    Four presentations by Dr. Ludwig Huber 
    - Recent Regulatory Updates and Trends in Analytical Method Validation
    - Lessons from Pharmaceutical Laboratory related FDA Warning Letters
    - FDA Compliance for Biopharmaceutical Laboratories
    - Regulatory Aspects of Biosimilar 'Generic' Drugs


  • November 19, 2015
    Learning from Recent Warning Letters related to Part 11 and Computer Validation

    With Clear Recommendations for Corrective and Preventive Actions
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room


  • October 15, 2015
    Transfer of Analytical Methods According to New FDA, USP and EU-GMP Guidelines
    With SOPs, templates and examples for easy implementation
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room


  • October 6-7, 2015, Live Public Seminar, Zurich, Switzerland
    Organized by GlobalCompliancePanel
    Validation and Part 11 Compliance of Computer Systems and Data
    Two-day Workshop

  • September 29 to, October 1, 2015: Munich, Frankfurt, Hannover: Germany
    Agilent Pharmaceutical Compliance Seminar Series
    Two presentations by Dr. Ludwig Huber
    - Recent Regulatory Updates and Trends in Analytical Method Validation
    - Lessons from Pharmaceutical Laboratory related FDA Warning Letter
    s

  • September 17, 2015
    Ensuring Integrity of Laboratory Data for FDA/EU Compliance
    With 10+ best practice guides for easy implementations
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room


  • August 20, 2015
    Understanding the Final FDA Guidance for Validation of Analytical Methods
    With 10+ best practice guides for easy implementation
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room
  • August 4-5, 2015, Live Public Seminar, San Francisco, USA
    Organized by ComplianceOnline
    Validation, Verification and Transfer or Analytical Methods  
    - Understanding and implementing guidelines from FDA/EMA, USP and ICH -
    Two-day Workshop

  • July 21, 2015
    FDA's New Enforcement of Part 11
    Learn what the FDA is looking for and how to respond
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room


  • July 16, 2015
    Analytical Instrument Qualification According the new Revision of USP <1058> 
    With SOPs, Templates and Examples for easy Implementation
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room


  • July 9, 2015
    Qualification of Virtual Networks and Cloud Computing
    With Strategies and Tool Kit for Compliance and System Uptime
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room
  • June 28 and June 30, 2015, Guangzhou and Beijing, China
    Agilent Pharmaceutical Compliance Seminar Series
    Three presentations by Dr. Ludwig Huber
    - Recent Regulatory Updates and Trends in Analytical Method Validation
    - Lessons from Pharmaceutical Laboratory related FDA Warning Letters
    - Ensure Integrity and Security of Laboratory Records for FDA Compliance
  • June 23 and June 25, 2015, Osaka and Tokyo, Japan
    Agilent Pharmaceutical Compliance Seminar Series
    Two presentations by Dr. Ludwig Huber
    - Recent Regulatory Updates and Trends in Analytical Method Validation
    - Lessons from Pharmaceutical Laboratory related FDA Warning Letters

  • June 15, 16, 17, 18, Lilly GMP Marathon, Branchburg NJ, USA
    Four presentations by Dr. Ludwig Huber
    - Quality by Design (QbD) for Development and Validation of Analytical Methods
    - Validation of Computerized Analytical and Networked Systems
    - Managing Out of Trend (OOT) Results in Pharmaceutical Quality Control
    - Lessons from Recent Quality Control Lab related FDA Warning Letter
    s
    2x4 two hour presentations
  • June 10, 2015, Heidelberg, Germany
    Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
    Ludwig Huber: three presentations/Case Study/Workshop
    1) FDA compliant RAW Data and other records
    2) Case Studies: Definition and handling of raw data - Applications in manufacturing and laboratory control
    3) Workshop: How to demonstrate data integrity for raw data
  • May 28, 2015
    New Guidelines and Trends in Method Validation and Transfer
    Comply with new FDA, EMA, USP and Industry Guidelines
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • May 21, 2015
    Managing Electronic Raw Data in Regulated Environments
    Definition, generation, evaluation and archiving for FDA, ICH, PIC/S and EU compliance
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • May 11-15, Boston, Bridgewater, Cary RTP, Chicago, San Francisco: USA
    Two presentations by Dr. Ludwig Huber
    - Recent Regulatory Updates and Trends in Analytical Method Validation
    - Lessons from Pharmaceutical Laboratory related FDA Warning Letters
  • May 7, 2015
    Implementing the New Final EU/PICS-GMP Annex 15 on Validation and Qualification
    New requirements and strategies for implementation
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room
     
  • April 23, 2015
    FDA Compliant IT Infrastructure and Network Qualification
    With Strategies and Tool Kit for Compliance and System Uptime
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room


  • April 16, 2015
    FDA Compliant Use of (Certified) Reference Material
    Strategies for selection, purchasing, testing and documentation
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room


  • April 9, 2015
    Lessons from Recent Quality Control Lab related FDA Warning Letters
    Learn how to use warning letters and 483s to other firms to design compliance into your lab
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room


  • April 1, 2015
    FDA/EU Compliant Handling of OOX Test Results

    Learn how to investigate out-of-trend (OOT) and out-of-expectation (OOE) vs. OOS results
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • March 26, 2015
    Quality by Design (QbD) for Development and Validation of Analytical Methods
    Learn how to design robust methods for easy transfer and to avoid OOS situations.
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room


  • March 15, 2015
    Validation and Use of Cloud Computing in FDA&EU Regulated Environments
    Comply with GXPs, Part 11, EU Annex 11 and other regulations
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room


  • March 4, 2015
    Risk Based Validation of Computers and Part 11 Compliance
    With Strategies for FDA/EU Compliance and Practical Tools for Effective implementation
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room


  • January 19/20, 2015, Live In-House Seminar at Roche, Singapore
    Validation and Part 11/Annex 11 Compliance of Computerized Analytical Systems and Data
    Two-day Workshop
  • January 22/23, 2015, Live Public Seminar, Singapore
    Validation and Part 11/Annex 11 Compliance of Computerized Analytical Systems and Data
    Two-day Workshop
  • January 27/28, 2015, In-House Seminar Glenmark, Mumbai, India
    Validation and Part 11/Annex 11 Compliance of Computerized Analytical Systems and Data
    Two-day Workshop

  • December 11, 2014
    Understanding and Implementing the New EU Annex 11
    Prepare Yourself for the upcoming Inspections and Enforcement
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room
  • December 1-2, 2014,  San Francisco
    GMP Compliance for Quality Control and Contract Laboratories
    2-Day Workshop, organized by ComplianceOnline
    For information on content, please contact Ludwig Huber
  • December 4-5, 2014, San Francisco
    Analytical Instrument Qualification and System Validation
    2-Day Workshop, organized by ComplianceOnlin
    e
  • November 20, 2014
    FDA Compliant HPLC Qualification and Performance Testing
    Learn how to select, conduct and document the right tests in the right sequence
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room
  • November 18, 2014, Heidelberg, Germany
    Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
    Ludwig Huber: three presentations/Case Study/Workshop
    1) FDA compliant RAW Data and other records
    2) Case Studies: Definition and handling of raw data - Applications in manufacturing and laboratory control
    3) Workshop: How to demonstrate data integrity for raw data
  • November 6, 2014
    New OECD Guide: Using Computer Systems in GLP Studies
    Understanding and Implementing the new OECD Guide for Computer Systems
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room
  • October 28, 2014
    Managing Out of Trend Results in Pharmaceutical Quality Control
    With Strategies and best Practice Guides for easy Implementation
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room
  • October 16-17, 2014, Chicago
    GMP Compliance for Quality Control and Contract Laboratories
    2-Day Workshop, organized by ComplianceOnline
  • October 21-22, 2014, Chicago
    Analytical Instrument Qualification and System Validation
    2-Day Workshop, organized by ComplianceOnline
  • September 30, 2014
    Review of Analytical Methods as Alternative to regular Revalidation
    Understand how to remain in compliance at much lower costs and at higher effectiveness
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room
  • September 4, 2014
    Computer System Validation: Step-by-Step
    With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room
  • August 26 - 29, 2014, China
    Beijing, Shanghai, Nanjing, Hangzho
    Agilent Pharmaceutical Seminar Series
    Two presentations by Dr. Ludwig Huber at each location
    - 60 min presentation: Lab Inspections based on US FDA and China GMPs
    -120 min Workshop: FDA 483 and Warning Letter Interpretation with real Case Studies
  • August 4, San Diego
    GMP Compliance for Quality Control and Contract Laboratories
    2-Day Workshop, organized by ComplianceOnline
  • August 4, San Diego
    Analytical Instrument Qualification and System Validation
    2-Day Workshop, organized by ComplianceOnline
  • July 31, 2014
    Learning from Recent Warning Letters Related to Computer Validation and Part 11
    With Clear Recommendations for Corrective and Preventive Actions
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room
  • July 24, 2014
    Handling Out-of-Specification Tests Results and Failure Investigations
    With Case Studies on how to Avoid and Respond to Recent 483s/Warning Letters
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room
  • June 27, Bangkok, Thailand
    Medical Sciences Center
    2 half-day workshops by Dr. Ludwig Huber
    Data Security, Control and Integrity
    - Understand and implement FDA Part 11 and the newPIC/S-EU GMP Annex 11
    Method Validation for Chemical Analysis
    - For ISO/IEC 17025 and GLP/GMP Compliance
  • June 24-26, 2014,
    Singapore, Kuala Lumpur, Bangkok
    Agilent Pharmaceutical Seminar Series
    Three presentations by Dr. Ludwig Huber at each location
    - Recent Regulatory updates and Trends in Pharmaceutical
      Laboratory Compliance  
    - Quality by Design –
      Regulatory Requirements and Impact on Laboratories
    - Workshop on Data Integrity:
       How to Prepare your Lab for Regulatory Inspections

  • June 23-24, 2014
    ISPE Conference Singapore
    2 Plenary lectures by DR. Ludwig Huber
    Analytical Validation in the Context of a Technology Transfer 
    QbD – Overview on Principle and Regulatory and Industry Activities
  • July 10, 2014
    Effective Validation of Analytical Methods for GLP and Clinical Studies
    Learn how to design, prepare, conduct and document for FDA Compliance
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room
  • June 18, 2014
    Auditing QC Laboratories for FDA Compliance
    Learn how to use internal audits in preparation for regulatory inspections
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room
  • June 12, London
    Analytical Instrument Qualification and System Validation
    2-Day Workshop, organized by ComplianceOnline
  • June 10, 2014
    Validation and Control of Excel Spreadsheets for FDA Compliance
    Understand requirements and get tool kits for easy implementation
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room
  • June 5, 2014
    Comparing GLP with GMP
    Learn about similarities and differences and when to apply one or the other
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room
  • June 3, 2014
    Recent Regulatory Updates in Pharma and Biopharma Compliance
    Get a comprehensive update in just one hour.
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room
  • May 22, Boston
    GMP Compliance for Quality Control and Contract Laboratories
    2-Day Workshop, organized by ComplianceOnline

  • May 19, Boston
    Analytical Instrument Qualification and System Validation
    2-Day Workshop, organized by ComplianceOnline

  • May 15, 2014
    Impact of Quality by Design on the Analytical Laboratory
    Learn through the example: Development and validation of analytical procedures-
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room
  • May 13, 2014, Heidelberg, Germany
    Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
    Ludwig Huber: three presentations/Case Study/Workshop
    1) FDA compliant RAW Data and other records
    2) Case Studies: Definition and handling of raw data - Applications in manufacturing and laboratory control
    3) Workshop: How to demonstrate data integrity for raw data
  • May 8/9, 2014, London, United Kingdom
    Analytical Instrumentation Qualification and System Validation
    2-Day In-person Seminar conducted by Dr. Ludwig Huber
    Please note: The same seminar will be delivered later in the United States (Boston, San Diego, Chicago, San Francisco) and in Singapore

  • May 5/6, 2014, Amsterdam, The Netherlands
    GMP Compliance for Quality Control and Contract Laboratories
    2-Day In-person Seminar conducted by Dr. Ludwig Huber
    Please note: The same seminar will be delivered later in the United States (Boston, San Diego, Chicago, San Francisco) and in Hong Kong

  • April 24, 2014
    Validation of Analytical Methods according to the New FDA Guidance
    -
    Understanding FDA's New Lifecycle Approach Towards Method Validation-
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • April 17, 2014
    Understanding Quality by Design for the Pharmaceutical Industry
    -
    Introduction to Principles, Regulatory Activities and Industry Practices-
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • April 7-11, 2014, India, 5 cities
    Agilent Pharmaceutical Seminar Series
    Two presentations by Dr. Ludwig Huber at each location
    - 60 min presentation: Recent Regulatory updates in
      Pharma and Biopharmaceuticals compliance and Q&A

    - 120 min Workshop: Avoid FDA Warning Letters through Ensuring Integrity of Electronic Records


  • April 3, 2014
    Understanding the New EU-GMP Annex 15 on Validation and Qualification
    -
    New requirements and strategies for implementation-
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • March 27, 2014
    Laboratory Equipment Calibration and Qualification according to
    USP <1058>

    With SOPs, Templates and Examples for easy Implementation
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • March 20, 2014
    Validation and Use of Cloud Computing in FDA Regulated Environments
    Comply with GXPs, Part 11, EU Annex 11 and other regulations
    March 20, 2014
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar roo
    m

  • March 04, Ho Chi Minh City, Vietnam
    Agilent Total Analytical Experience (TAE) Seminar
    Three plenary lectures by Dr. Ludwig Huber
    - ISO 17025 and Pharma GLP/GMP Compliance in Laboratories
    - US & EU GMP guidelines on Analytical Instrument
      Qualification and related warning letters
    - Importance of instrument validation for accredited food
      export testing labs

  • March 03, Bangkok, Thailand
    Medical Sciences Center
    Lecture by Dr. Ludwig Huber
    - Quality Systems and Regulations for Laboratories
      -
    Understanding and Implementing GxP and ISO 17025 -

  • February 27, 2014, Sydney, Australia
    Royal Australian Chemical Institute - Pharmaceutical Science Group
    Three plenary lectures by Dr. Ludwig Huber
    - Integrated Method Development and Validation
    - Laboratory Computer System Validation
    - Inter-Laboratory Method Transfer


  • February 25, 2014, Seoul, Korea
    Agilent Pharmaceutical Seminar Series
    Two presentations by Dr. Ludwig Huber
    - Quality by Design (QbD)
      Introduction to Principles, Regulatory activities and Industry Practices
    - QbD for Analytical Method Development and Validation Letters


  • February 20, 2014
  • EU Compliant IT Infrastructure and Network Qualification
    With Strategies and Tool Kit for Compliance and System Uptime
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • February 13, 2014
    Understanding the 'New' FDA Guide for Validation of Bioanalytical Methods
    With SOPs, templates and examples for easy implementation
    February 13, 2014
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • January 30, 2014
    Transfer of Analytical Methods According to the New USP Chapter <1224>
    With SOPs, templates and examples for easy implementation
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • January 23, 2014
    Understanding FDA's New Guide on Use of Electronic Source Data in Clinical Investigations
    With tool kit for cost effective implementation
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • December 5, 2013
    Are You ready for FDA's 'New' Inspection and Enforcement Practices?
    With Industry Proven Tool Kits for Preparation, Conduct and Follow-up
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room
  • November, 2014, Heidelberg, Germany
    Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
    Ludwig Huber: three presentations/Case Study/Workshop
    1) FDA compliant RAW Data and other records
    2) Case Studies: Definition and handling of raw data - Applications in manufacturing and laboratory control
    3) Workshop: How to demonstrate data integrity for raw data
  • November 21, 2013
    GMP Compliance for Quality Control and Contract Laboratories
    Up-to-date FDA/EMA Requirements and Tools for Cost Effective Implementation
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • October 31, 2013
    Quality by Design (QbD) for Development and Validation of Analytical Methods
    Learn how to apply modern Lifecycle Management for Analytical Methods
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • October 17, 2013
    Elemental Impurities According to the new ICH Q3D and USP 232/233 Guidelines
    With updates on selected elements, limits, analytical procedures and schedule
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • October 19, 2013
    FDA Compliant Use of (Certified) Reference Material
    Strategies for selection, purchasing, testing and documentation
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • September 26, 2013
    Managing Electronic Raw Data in Regulated Environments
    Definition, generation, evaluation and archiving for FDA, ICH, PIC/S and EU compliance
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • September 12, 2013
    Integrated Analytical Equipment Qualification and System Validation for FDA Compliance 
    Combining the USP <1058> with the new GAMP(TM) Laboratory Computer Systems Guide
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • September 5,  2013
    System Suitability Testing for FDA and USP Compliance
    Setting parameters and limits for chromatographic and other methods
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • August 15, 2013
    Basic and update Training on Good Manufacturing Practices
    Ideal as Introduction for new Employees and as Refresher for all others
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • August 1, 2013
    FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control
    With Strategies and best Practice Guides for easy Implementation
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • July 25, 2013
    Validation and Use of Cloud Computing in FDA Regulated Environments
    Comply with GXPs, Part 11, EU Annex 11 and other regulations
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • June 13, 2013
    Validation and Use of Excel Spreadsheets in Regulated Environments
    Comply with GxPs for drugs, APIs and Devices, with FDA Part11, and with EU-PIC/S Annex 11
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • June 27 2013
    Regulatory Aspects of Biosimilar 'Generic' Drugs
    Understand and Implement recent FDA and updated EMA Guidances
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • May 23 2013
    How to ensure Part 11 compliant Integrity of Laboratory Data
    Comply with new FDA inspection practices and EU Annex 11 requirements
    One hour Labcompliance Audio Seminar
    Learn at your desk or with your colleagues in your seminar room

  • May 14, 2013
    FDA/EMA Compliance of Genotoxic Impurities
    Understanding and Implementing the new ICH M7 and other Guidelines
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or with your colleagues in your seminar room

  • May 7, 2013
    Comparing GLP with GMP
    Learn about similarities and differences and when to apply one or the other
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • April 25, 2013
    Elemental Impurities According to the Final USP Chapters 232/233
    With updates on the new ICH Q3D Guide: Elements, Limits and Schedule
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room
  • April 10, 2013, Ho Chi Minh City, Vietnam
    Agilent Pharmaceutical Seminar Series
    Two presentations by Dr. Ludwig Huber
    - Overview of current regulatory situation in Generic pharma QA/QC
    - 90 minutes compliance interactive session Part 1 and Part 2
      How to select parameters and limits for validation, verification
      and transfer of analytical methods

  • April 17, 2013, Analytica Vietnam, HohChiMinh City
    Dr. Ludwig Huber Presentations / Interactive Workshop
    Plenary lecture
    - Quality Assurance and Compliance in Laboratories
    Full day workshop
    - Equipment Qualification and System Validation in
      Regulated Laboratories

  • March 21, 2013
    Transfer of Analytical Procedures According to the New USP Chapter <1224>
    With SOPs, templates and examples for easy implementation
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • March 7, 2013
    Setting up a Quality System for Pharmaceutical Laboratories
    Understanding and Implementing ICH Q10 and other Quality Systems
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • February 27, 2013, Bangladesh
    Agilent Pharmaceutical Seminar Series, Dhaka
    Dr. Ludwig Huber Interactive Workshop
    - How to Avoid and Respond to FDA Warning Letters

  • February 25, 2013, Singapore
    IVT’s Validation Week
    Dr Ludwig Huber: 90 minutes interactive discussion session
    Qualification of Virtual Networks and Cloud Computing

  • February 25, 2013, Singapore
    IVT’s Validation Week
    Dr Ludwig Huber:
    90 minutes interactive discussion session
    Prepare for and Handle Validation Inspections

  • February 26, 2013, Singapore
    IVT’s Validation
    Week
    Dr Ludwig Huber: 90 minutes interactive discussion session
    Build a Cohesive and Efficient Validation Master Plan


  • February 25, 2013, Singapore
    IVT’s Validation
    Week
    Dr Ludwig Huber: 60 min opening presentation
    Regulatory Trends and Updates —
    Review of Global Guidelines and Regulations Impacting Validation Professional
    s

  • February 18-22, 2013, Japan
    Agilent Pharmaceutical Seminar Series, Tokyo/Osaka
    Dr. Ludwig Huber Presentations / Interactive Workshops
    - Setting up a Quality System for Pharmaceutical Laboratories
    - Validation of Computerized Laboratory Systems
    - How to Avoid and Respond to FDA Warning Letters
    - Quality and Compliance for the Biopharmaceutical Laboratory


  • February 14, 2013
    How to Efficiently Build a GLP Laboratory
    Step-by-step from design to cost-effective implementation
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • February 9, 2013
    Efficient Training Practices for FDA and International Compliance
    What to train - How much to Train - How to Document Effectiveness
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • January 24, 2013
    Quality by Design (QbD) for  Analytical Method Development and Validation
    Learn how to design robustness for easy transfer and to avoid OOS situations
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • January 22, 2013, France
    Agilent Pharmaceutical Seminar Series,
    Paris
    Dr. Ludwig Huber Presentations
    - Update on Latest Trends in Pharma Compliance
    - Elemental Impurities According to USP Chapters <232> and <233>,
      with updates on ICH Q3D
    - Analytical Instrument Qualification and System Validation
      According to USP<1058>

  • January 10, 2013
    FDA Compliant IT Infrastructure and Network Qualification
    With Strategies and Tool Kit for Compliance and System Uptime
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • December 20, 2012
    Understanding and Implementing the New EU Annex 11
    Prepare Yourself for the upcoming Inspections and Enforcement
    One hour Labcompliance Audio Seminar
    Learn at your desk or in your seminar room

  • December 13, 2012
    Validation and Use of Cloud Computing in FDA Regulated Environments
    Comply with GXPs, Part 11, EU Annex 11 and other regulations
    One hour Labcompliance Audio Seminar
    Learn at your desk or in your seminar room

  • November 29, 2012
    Validation of Analytical Methods for GLP and Clinical Studies
    Learn how to design, prepare, conduct and document for FDA Compliance
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • November 19-22, 2012, China
    Agilent Pharmaceutical Seminar Series,
    Shanghai, Beijing, ChongQing, Lianyungang

    Dr. Ludwig Huber Presentations / Interactive Workshop
    - How to Avoid and Respond to FDA Warning Letters

    - PIC/S-EU GMP Annex 11 - The new Golden Regulatory
      Standard for Computer Validation and Management
    - Analytical Instrument Qualification and System Validation
    - Eight Essential Steps for Cost-effective Laboratory Compliance

  • November 20, 2012
    Pharmacy Engineering and Drug Quality Conference, 2012 
    Dr. Ludwig Huber
    Plenary Lecture
    - Computer System Validation -
      Requirements and Recommendations for Implementation

  • November 15, 2012
    Using Electronic and Digital Signatures in Regulated Environments
    Comply with FDA Part 11 and international regulations and guidelines
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • October 25, 2012
    Cost Effective Validation of Laboratory Computer Systems
    With industry proven examples for all validation steps
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • October 11, 2012
    Calibration and Qualification of Stability Chambers
    Learn how to select, conduct and document the right test parameters and conditions
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • September 27, 2012
    Laboratory Equipment Qualification according to USP <1058> 
    With SOPs, Templates and Examples for Easy Implementation
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • September 13, 2012
    FDA Compliant Use of (Certified) Reference Material
    Strategies for selection, purchasing, testing and documentation
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • August 30, 2012
    Verification of Compendial Methods according to the Revised USP Chapter <1226>
    Understand the new risk based approach and get real world case studies for testing
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • July 26, 2012
    Implementing the New USP Chapters 232/233 for Elemental Impurities
    Learn how to comply with FDA, USP and ICH Requirements
    One hour Labcompliance Audio Seminar (294)
    Learn at your desk or in your seminar room

  • July 12, 2012
    Qualification and Use of Virtual Networks in Regulated Environments
    With Strategies and Tool Kit for Compliance and System Uptime
    One hour Labcompliance Audio Seminar (294)
    Learn
    at your desk or in your seminar room

  • July 10 2012
    Selecting Acceptance Criteria for Regulatory Method Validation
    Learn through case studies and get inspection ready documentation
    One hour Labcompliance Audio Seminar (293)
    Learn
    at your desk or in your seminar room

  • June 21, 2012
    Validation and Use of Excel Spreadsheets in Regulated Environments
    For pharmaceutical, medical device and API industry
    One hour Labcompliance Audio Seminar (292)
    Learn
    at your desk or in your seminar room
  • May 24, 2012
    Configuration Management and Change Control for Networks and Computer Systems
    Changes of Hardware, Firmware, Software, Networks, Documentation
    One hour Labcompliance Audio Seminar (291)
    Learn
    at your desk or in your seminar room

  • May 8, 2012
    Ensuring Integrity and Security of Electronic Records for FDA Compliance
    Comply with new FDA inspection practices and EU Annex 11 requirements
    One hour Labcompliance Audio Seminar (290)
    Learn
    at your desk or in your seminar room

  • April 26, 2012
    How to Survive FDA's 'New' Inspection and Enforcement Practices
    With Industry Proven Tool Kits for Preparation, Conduct and Follow-up.
    One hour Labcompliance Audio Seminar (289)
    Learn
    at your desk or in your seminar room

  • April 12, 2012
    FDA Compliant Sampling and Sample Handling in Laboratories
    Strategies to Avoid Sampling Errors and Ensure Sample Integrity
    One hour Labcompliance Audio Seminar (288)
    Learn
    at your desk or in your seminar room

  • March 29, 2012
    Eight Steps for Cost-effective Laboratory Compliance
    Up-to-date overview, hot topics and trends. With tool kit for easy implementation
    One hour Labcompliance Audio Seminar (287)
    Learn
    at your desk or in your seminar room

  • March 15, 2012
    Implementing the New USP Chapter <1224> for Analytical Method Transfer
    With SOPs, templates and examples for effective implementation
    One hour Labcompliance Audio Seminar (286)
    Learn
    at your desk or in your seminar room

  • February 16, 2012
    FDA/EU Compliant Training for Laboratory Personnel
    What to train - How much to Train - How to Document Effectiveness
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • February 28, 2012, Singapore
    IVT’s Validation and Compliance Congress
    Achieve Manufacturing Excellence through Optimal Quality Practice
    90 min Discussion Session:  
    Qualification of Virtual Networks and Cloud Computing

  • February 28, 2012, Singapore
    IVT’s Validation and Compliance Congress
    Achieve Manufacturing Excellence through Optimal Quality Practice
    90 min Discussion Session: 
    Change Control and Configuration Management for Software and Computer System

  • February 9, 2012
    Qualification of Virtual Networks and Cloud Computing
    With Strategies and Tool Kit for Compliance and System Uptime
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • January 26, 2012
    Quality by Design (QbD) for  Development and Validation of Analytical Methods
    Learn how  to design robustness for easy transfer and to avoid OOS situations
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • January 12, 2012
    FDA Compliant SFC Qualification and Performance Testing
    Learn how to select, conduct and document the right tests in the right sequence
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • December 20, 2011
    FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control
    With Strategies and best Practice Guides for easy Implementation
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • December 13, 2011
    Validation of Analytical Methods and Procedures: Step by Step
    Design, Conduct and Document for Efficiency and FDA Compliance
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • December 1, 2011
    Cost Effective Computer System Validation: Step-by-Step
    With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • November 17 2011
    How to get the most out of Supplier Support  for Equipment and Computer
    Strategies for suppliers to maximize business and for users to minimize validation cost
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • November 10, 2011, Hongkong
    Agilent Pharmaceutical Seminar Series, China/
    Hongkong
    Interactive Workshops: (150 minutes)
    - Validation of Chromatographic Data Systems – Step-by-Step
    - Ensuring Integrity and Security of Laboratory Data
    - Validation of Analytical Procedures for FDA and ISO 17025 Compliance

  • November 8, 2011, Taizhou
    Agilent Pharmaceutical Seminar Series, China
    Plenary lectures:
    - How can China Pharma Manufactures Overcome the Increasing Challenges from FDA /EU Regulations
    - Calibration and Qualification in Laboratories
    - The Importance Electronic e-Records and Computer System Validation for FDA/EU Inspections
    I
    nteractive Workshop (2 1/2 hours)
      Preparation for EU/FDA Inspections

  • November 5/6, 2011
    2 day workshop, Peking University, Beijing, China
    Equipment Qualification and Calibration in Laboratories

  • October 20, 2011
    Learning from Recent Warning Letters Related to Computer Validation and Part 11
    With Clear Recommendations for Corrective and Preventive Actions
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • October 18, 2011
    IT Infrastructure and Network Qualification: Step-by-Step
    With Strategies and Tool Kit for Compliance and System Uptime
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • October 13, 2011, Mumbai, India
    Effective Method Validation for FDA/EU Compliance
    One day workshop
    Anacon/Analytica India

  • September 22,  2011
    Good Laboratory Practice Regulations Introduction and Strategies for Implementation
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • September 15/16 , 2011, Mumbai, India
    Validation and Part 11 Compliance of Computer Systems
    Two Day US FDA India Seminar
    GlobalCompliancePanel

  • September 12/13  13, 2011, Chennai India
    Validation and Part 11 Compliance of Computer Systems
    Two Day In-house n-house workshop
    GlobaCompliancePanel

  • September 8,  2011
    Ensuring Integrity and Security of Laboratory Data
    Comply with new FDA inspection practices and EU Annex 11 requirement
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • September 1,  2011
    Verification of Compendial Methods according to the New USP Chapter <1226>
    Understand the new risk based approach and and get real world case studies for testing
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • August 23 and 25, 2011, Shijiazhuang and Guangzhou
    Agilent Pharmaceutical Seminar Series, China
    Plenary lectures:
    - How can China Pharma Manufactures Overcome the Increasing Challenges from FDA /EU Regulations
    - Calibration and Qualification in Laboratories
    - The Importance Electronic e-Records and Computer System Validation for FDA/EU Inspections
    I
    nteractive Workshop (2 1/2 hours)
      Preparation for EU/FDA Inspections

  • August 11, 2011
    Understanding the New USP Chapters 232/233 for Metal Impurities
    Become familiar with FDA regulations and get tool kits for implementation .
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • July 28, 2011
    Periodic Review and Evaluation of Computer Systems
    With strategies and tools for FDA and EU compliance
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • July 14, 2011
    How to Prepare Yourself for FDA's on-going Part 11 Inspection Program
    Learn what the FDA is looking for and how to respond
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • July 4-8, 2011
    Agilent Pharmaceutical Seminar Series, INDIA
    - Chandigarh
    - Mumbay
    - Ahmedabad
    - Hyderabad
    - Bangalore

    Plenary lecture:
    - Updates on USP Chapters <232/233> for Analysis of Metal Impurities
    Interactive Workshop (2 1/2 hours)
     
    What Every Lab Manager Must Know About Compliance

  • June 30, 2011
    Bioanalytical Methods Validation
    Conduct and Document for Efficiency and FDA&EMA compliance
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • June 16, 2011
    FDA Compliance for Biopharmaceutical Laboratories
    Become familiar with FDA regulations and get tool kits for implementation .
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • June 7/8, Istanbul, Turkey
    FDA/EU GMP Compliance for Quality Control and Contract Laboratories
    Two day workshop

  • May 26, 2011
    Raw Data in FDA Regulated Environments
    FDA/EU compliant recording, maintenance and archiving
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • May 9, 2011, In-house Seminar, J&J, Leiden, The Netherlans
    Analytical Instrument Qualification According to USP Chapter <1058>
    One day workshop

  • May 5, 2011
    How to Develop an FDA/EU Compliant Risk Management Master Plan
    The most important document for efficient and consistent risk management.
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • April 28, 2011
    Validation and Use of Excel Spreadsheets in Regulated Environments
    Comply with FDA Part 11, the PIC/s Good Practice Guide and the
    EU Annex 11.
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • April 14, 2011
    Auditing Computer Systems for Part 11 and Annex 11 Compliance
    Prepare your organization for upcoming FDA and EU inspections
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • April 8, 2011, Ho Chi Minh, Vietnam
    Effective Method Validation for FDA/EU Compliance
    One day workshop
    Analytica Vietnam

  • April 8, 2011, Ho Chi Minh, Vietnam
    Quality Assurance and Compliance in Analytical Laboratories
    Plenary Lecture
    Analytica Vietnam,

  • March 24, 2011
    Learning from Recent Warning Letters Related to GMP Laboratory Controls
    For Preparation of FDA and International GMP Laboratory Inspections
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • March 28 to April 5
    Agilent Pharmaceutical Seminar Series-
    - Kuala Lumpur, Malaysia
    - Bangkok, Thailand
    - Ho Chi Minh City, Vietnam
    Plenary lecture:
    - Global Regulatory Trends-
      Updates and Initiatives from US FDA, Europe, PIC/S and USP

    -
    Interactive Workshop
     What Every Lab Manager Must Know About Compliance:

  • March 10, 2011
    Transfer of Analytical Methods According to the New USP <1224>
    With SOPs, templates and examples for easy implementation
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • March 3/4, 2011, Seoul, Korea
    Two day joint conference with the Korean Food and Drug Administration (KFDA) and the Korean Pharmaceutical Manufacturing Association (KPMA)
    - Plenary lecture: FDA/EU GMP Compliance for Laboratories: Lab Compliance for QC or CRO labs 
    - Workshop: Requirement Management for Equipment and Computer system:  Analytical Instrument Qualification and its implementation
    - Workshop: Management and Validation of Computer Systems for FDA's 21 CFR Part 11

  • February 28
    Agilent Pharmaceutical Seminar Series-
    -
    Singapore
    Plenary lecture:
    - Global Regulatory Trends-
      Updates and Initiatives from US FDA, Europe, PIC/S and USP

    -
    Interactive Workshop
     What Every Lab Manager Must Know About compliance:


  • February 25, Singapore
    IVT’s Validation and Compliance Congress
    Achieve Manufacturing Excellence through Optimal Quality Practice
    90 min Discussion Session:  Eight Steps for Cost-Effective Validation of Software and Computer Systems

  • February 23, Singapore
    IVT’s Validation and Compliance Congress
    Achieve Manufacturing Excellence through Optimal Quality Practice
    1/2 Day Workshop:  Develop a GMP Roadmap for Effective Laboratory Compliance

  • February 16, 2011, Vienna, Austria
    Agilent Pharmaceutical Conference
    Analysis of Metal Impurities According to New USP Chapters
    Understanding the Proposed USP Chapters <232>, <233> and <2232> for Elemental Impurities


  • February 15, 2011, Heidelberg, Germany
    Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
    Ludwig Huber: three presentations/Case Study/Workshop
    1) FDA compliant RAW Data and other records
    2) Case Studies: Definition and handling of raw data - Applications in manufacturing and laboratory control
    3) Workshop: How to demonstrate data integrity for raw data

  • February 10, 2011
    Understanding and Implementing the New EU Annex 11
    Learn about specific requirements and get tools for implementation
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • February 3, 2011
    Learning from Recent Warning Letters Related to Good Laboratory Practices
    For Preparation of FDA and International GLP Inspections
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room
  • January 27, 2011
    Development and Validation of Stability Indicating Methods for FDA/ICH Compliance
    Sample generation - method development - validation - documentation
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room
  • December 16
    Revalidation of Computer Systems for FDA&EU Compliance
    FDA/EU requirements and strategies and tools for implementation
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • December 7, 2010, Singapore
    Pharma Compliance Seminar for 3M
    FDA/EU Compliance for Quality Control Laboratories
    1 Day Workshop


  • December 3, 2010, Manila, Philippines, Shangri-La Hotel
    Agilent Pharmaceutical Seminar
    - Plenary lecture: Updates on Regulations for Compliance and validation
    - 2 x 1 hour:  Step by step – How to Perform Compliance and Validation in Laboratories

  • November 30, 2010, Jakarta, Indonesia
    Agilent Pharmaceutical Seminar
    - Plenary lecture: Updates on Regulations for Compliance and validation
    - 2 x 1 hour:  Step by step – How to Perform Compliance and Validation in Laboratories


  • November 25, 2010, Sydney, Australia
    Royal Australian Chemical Institute - Pharmaceutical Science Group
    - Effective HPLC Method Development and Validation
    - Eight Steps for Cost-effective Software and Computer System Validation

  • November 24, 2010, Melbourne, Australia
    Half Day Agilent Pharmaceutical Seminar
    - Plenary lecture: Global regulatory trend updates and initiatives-
    - Workshop: Validation of Analytical Methods and Procedures
    - Discussion: System Suitability Testing for FDA/USP Compliance

  • November 18
    Validation of Existing/Legacy Computer Systems for FDA/EU Compliance
    FDA/EU requirements and strategies and tools for implementation.
    One hour Labcompliance Audio Seminar
    Learn at your desk or in your seminar room

  • November 11, 2010
    How to Prepare Yourself for FDA's New Part 11 Inspection Program
    Learn what the FDA is looking for and how to respond
    One hour Labcompliance Audio Seminar
    Learn
    at your desk or in your seminar room

  • November 11, 2010
    How to Prepare Yourself for FDA's New Part 11 Inspection Program
    Learn what the FDA is looking for and how to respond
    One hour Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • October 28
    Validation of Excel® Spreadsheets: Step-by-Step
    With Case Studies and Validation Protocols for Easy Implementation.
    One hour Labcompliance Audio Seminar
    Learn from your desk or in your seminar room
  • October 26
    Validation of Excel® Spreadsheets: Step-by-Step
    With Case Studies and Validation Protocols for Easy Implementation.
    Full day ComplianceOnline Web Seminar Seminar
    Learn from your desk or in your seminar room
  • October 21
    Effective HPLC Method Development and Validation
    Preparation, conduct and documentation for FDA/EMA compliance
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • October 7, 2010
    FDA Compliant Use of (Certified) Reference Material
    Strategies for selection, purchasing, testing and documentation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room
  • September 23, 2010
    FDA Regulations for (Bio)Pharmaceutical Industry
    Get an Overview on Principles and Key Requirements in just one Hour
    One hour Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • September 16-17, Shanghai
    Analytica China, 2-day workshop
    FDA/EU Compliance for Quality Control Laboratories

  • September 15, Shanghai
    Analytica China, Plenary Lecture
    Effective Method Validation for ISO 17025 and GLP/GMP Compliance

  • September 9, 2010
    System Suitability Testing for FDA and USP Compliance
    With 10+ Best Practice Guides for Easy Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • September 7, 2010, Basel - Switzerland
    Agilent Pharmaceutical Conference
    Analysis of Metal Impurities According to New USP Chapters
    Understanding the Proposed USP Chapters <232>, <233> and <2232> for Elemental Impurities

  • August 9 to August 13
    Agilent Pharmaceutical Seminar Tour
    Bangalore, Hyderabad, Ahmedabad, Mumbai - India
    - Plenary Lecture: USP Updates on Method Validation and Transfer
    - 1/2 Day Workshop: Apply Risk Based Compliance to Laboratories


  • August 5, 2010
    Understanding and Preparing for FDA's New Part 11 Inspection Program
    With 10+ Best Practice Guides for Easy Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar roo
    m

  • July 22, 2010
    Recent Warning Letters and 483's Related to Computer Validation and Part11 
    With Clear Recommendations for Corrective and Preventive Actions

  • July 8, 2010
    Analytical Instrument Qualification According to USP <1058>
    With SOPs, Templates and Examples for Easy Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • June 24, 2010
    GMP Compliance for Quality Control Laboratories: Step-by-Step
    FDA Requirements and Tools for Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • June 10, 2010
    Electronic Raw Data in Regulated Environments
    Definition, generation and archiving for FDA Part 11, HIPAA and SOX compliance
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • May 27, 2010
    Implementing FDA's 21 CFR 111 for Dietary Supplements
    Introduction, Strategies and Tool-kit for Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • May 12, 2010
    How much Validation is Enough?
    Developing a Company Wide Strategy and Tools for Cost-effective Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • May 11 , 2010, Heidelberg, Germany
    APV Seminar: Network Infrastructure Qualification (in German)
    Risk Assessment for Networks

  • May 6, 2010, Paris, France
    Agilent Pharmaceutical Conference
    Analysis of Metal Impurities According to New USP Chapters
    Understanding the Proposed USP Chapters <232>, <233> and <2232> for Elemental Impurities

  • April 29, 2010
    FDA's 21 CFR Part 11
    Introduction and Strategies and Tools for Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • April 22, 2010
    Practical Risk Assessment in Laboratories: Step-by-Step
    With Risk Master Plan, SOPs and Case Studies for Easy Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • April 15, 2010
    The Qualified Person in the Pharmaceutical Industry
    Understanding Qualification Requirements, Tasks, Duties and Responsibilities
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • March 31, 2010
    Qualification and Calibration of Stability Chambers
    Learn how to select, conduct and document the right test parameters and conditions
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room
  • March 25, 2010
    Documentation for FDA and ISO 17025 Compliance
    Step-by-step Instructions with Sample Documents
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room
  • March 23, 2010, Dublin, Ireland
    IVT Conference - European Validation Week
    90 min Interactive Discussion Session  
    Implementing New USP Chapters for Analytical Method Validation
  • March 23, 2010, Dublin, Ireland
    IVT Conference - European Validation Week
    90 min Interactive Discussion Session  
    Equipment Qualification – Determine and Demonstrate “Fit for Intended Use”
  • March 22, 2010, Dublin, Ireland
    IVT Conference - European Validation Week
    Plenary Lecture 
    How Much Validation is Enough
  • March 19, 2010, Ho Chi Minh, Vietnam
    Sheraton Hotel
    Agilent Pharmaceutical Seminar
    - Plenary lecture: Updates on Regulations for Compliance and validation
    - 2 x 1 hour:  Step by step – How to Perform Compliance and Validation in Laboratories

  • March 15, 2010, Seoul, Korea
    Agilent Pharmaceutical Seminar
    - Plenary lecture: Global regulatory trend updates and initiatives
    - Half Day Workshop: Apply Risk based methodology in Compliance

  • March 12, 2010, Singapore
    Agilent Pharmaceutical Seminar
    - Plenary lecture: Global regulatory trend updates and initiatives
    - Half Day Workshop: Apply Risk based methodology in Compliance

  • March 11, 2010, Kuala Lumpur, Malaysia
    Agilent Pharmaceutical Seminar
    - Plenary lecture: Global regulatory trend updates and initiatives
    - Half Day Workshop: Apply Risk based methodology in Compliance

  • March 8, 2010, Heidelberg, Germany
    Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
    Ludwig Huber: three presentations/Case Study/Workshop
    1) FDA compliant RAW Data and other records
    2) Case Studies: Definition and handling of raw data - Applications in manufacturing and laboratory control
    3) Workshop: How to demonstrate data integrity for raw data

  • March 4, 2010
    How to Efficiently Get ISO 17025 Accreditation
    Step-by-step from the idea to cost-effective implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • March 3, 2010
    Analysis of Metal Impurities According to New USP Chapters

    Understanding the Proposed USP Chapters <232>, <233> and <2232> for Elemental Impurities
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • February 25, 2010
    Simplify Validation and Qualification with ASTM E2500
    Cost Effective Alternative for Equipment Qualification and System Validation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • February 18, 2010
    Validation and Use of Excel® Spreadsheets in Regulated Environments
    Comply with GxPs, Part11, HIPAA, SOX and other regulations.
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • February 4, 2010
    Validation of Analytical Methods and Procedures
    Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025 Compliance
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • Jan 29/30, 2008, Heidelberg, Germany (in German)
    Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs (in German)
    Ludwig Huber: two presentations
    Validation and Qualification of Computer Systems
    Analytical Equipment Qualification


  • January 21, 2010
    Stability Testing in Pharmaceutical and API Industry
    Learn how to design, conduct and document studies for FDA and ICH
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • January 14, 2010
    Computer System Validation: Step-by-Step
    With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room
     
  • December 10, 2009
    FDA Compliant Transfer of Analytical Methods
    Prepare your Lab for the NEW USP General Chapter
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room
     
  • December 3, 2009
    FDA's New Enforcement of 21 CFR Part 11
    Strategies and Tools to implement FDA's New E-records&Signatures Directions
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room
     
  • November 17, 2009
    How to Efficiently Build a GLP Laboratory
    Step-by-step from design to cost-effective implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • November 5, 2009
    FDA Compliant HPLC Qualification and Performance Testing
    Learn how to select, conduct and document the right tests in the right sequence
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • October 23, 2009
    Handling Out-of-specification Situations and Faiure Invrestigations
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • October 8, 2009
    Agilent Lab Informatics Conference
    Plenary Lecture: Cost Effective Software and Computer System Validation

  • September 30, 2009
    Plenary Lecture: Analytca Hyderbad (Anacon India)
    Quality Assurance and Compliance in Laboratories

  • September 25 and 30, 2009
    Agilent VIP Meeting, Bangalore/Hyderabad, India
    Plenary Lecture: Crafting an efficient & cost-effective Lab Compliance Program

  • September 22/24, 2009 ,
    Hyderabad, Ahmedabad, Mumbai: India
    USP/Agilent Compliance Seminar Series
    Ludwig Huber - 2 Workshops New and Updated USP Chapters
    - Analyical Instrument Qualification (USP 1058)
    - Validation of Analytical Methods and Procedures (USP 621/1226)

  • September 17, 2009
    Calibration and Qualification in Analytical Laboratories
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • September 5/6, 2009
    2 day workshop, Peking University, Beijing, China
    Practical Validation of Computer Systems in Analytical Laboratories
  • September 3/4, 2009
    2 day workshop, Peking University, Beijing, China
    Analytical Instrument Qualification and Calibration

  • July 30, 2009
    Six Steps to Successful FDA Inspections
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • July 23, 2009
    Understanding and Implementing ISO 17025
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • July 9, 2009
    Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control
    Comply with the FDA and international guidances
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  •  June 18, 2009
    Latest Updates on Software and Computer System Compliance
    Learn from most recent conferences
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • June 10-12, 2009 ,
    Korea Seoul
    Agilent VIP Compliance Seminars
    Update on Worldwide Regulatory Compliance Initiatives
    Ludwig Huber
    4 Plenary Lectures
    - Workflow of the analytical process and compliance overview
    - Traceability and Measurement Uncertainty in Chemical Analysis
    - Management and Validation of Computers for ISO 17025
    - Requirement Management for Equipment and Computer Systems


  • June 9, 2009 ,
    Korea Seoul
    Agilent Public Compliance Seminar
    Ludwig Huber - 6 Plenary Lectures
    - FDA’s New Globalization Act : Initiatives for more frequent foreign inspections -
      Impact on Pharmaceutical Companies and API manufacturers in Korea
    - Impact of ISO 17025 on Pharma and non-Pharma Testing Laboratories
    - Regulatory Requirements for Computer Systems
    - Understanding and Implementing the New EU Annex 11:
      Comparison to FDA 21 CFR Part 1
    - Validation of Chromatographic Data Systems in Practice
    - Managing Analytical Raw Data in Regulated Environments


  • June 8, 2009 ,
    Korea Seoul
    Agilent Compliance Seminar for KFDA
    Ludwig Huber - 4 Plenary Lectures
    - Update on WW Regulatory Compliance Initiatives for Pharma and
      non-Pharma
    - FDA’s New Globalization Act
    - The New EU Annex 11 on Using Computers in GMP Environments
    - Impact of ISO 17025 on Pharma and non-Pharma Testing Laboratories


  • June 4 and 5, 2009 ,
    Suzhou, Tianjin: China
    Agilent Compliance Seminar Series
    Ludwig Huber - 3 Plenary Lectures
    - The FDA Globalization Act of 2009
    - The New EU Annex 11 on Using Computers in GMP Environments
    - Update on USP Chapter <621>


  • June 2, 2009, Singapore
    ISPE Interphex
    Plenary Lecture -  
    Understanding and Implementing the New EU Annex 11

  • May 28, 2009
    Risk Based Computer System Validation and Part 11 Compliance
    With Strategies for FDA/EU Compliance and Practical Tools for Effective implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • May 20, 2009, Washington. USA
    IVT Conference - Computer System Validation
    90 min Interactive Discussion Session  
    Understanding and Implementing FDA Audit Trail Requirements

  • May 19, 2009, Washington. USA
    IVT Conference - Computer System Validation
    90 min Interactive Discussion Session  
    Implementing New Guidelines for Validation of Laboratory Data Systems

  • May 18, 2009, Washington. USA
    IVT Conference - Computer System Validation
    Plenary Lecture -  
    Understanding and Implementing the New EU Annex 11

  • May 14, 2009
    Effective Verification of Compendial Methods
    Understanding USP and FDA Requirements and get Tools for Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • April 30, 2009
    Traceability in Chemical Analysis
    With strategies and tools for ISO 17025 and FDA Compliance
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • April 23, 2009
    IT Infrastructure and Network Qualification
    Introduction and Strategies for Compliance and System Uptime
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • April 21/22, Mannheim, Germany
    Concept-Heidelberg Conference: Pharma Lab Manager Conference (in German)
    Ludwig Huber: Plenary Lecture
    Practical Impact of USP <1058>, GAMP 5 and the New Annex 11 on Laboratories
  • April 8, 2009
    Management and Validation of Computers for ISO 17025
    Requirements, Recommendations and Tools for Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • March 25-April 2, 2009 ,
    Mexico City - San Juan - Rio de Janeiro - Sao Paulo - Buenos Aires
    Agilent Compliance Seminar Series
    Ludwig Huber - 4 Plenary Lectures
    - Regulatory Requirements for Computer Systems
    - Validation of Chromatographic Data Systems in Practice
    - Managing Analytical Raw
    Data in Regulated Environments
    - Successful FDA Inspection

  • March 20, 2009
    Understanding and Implementing ISO 17025
    One day workshop
    Analytica Vietnam, Hanoi
  • March 19, 2009
    Effective Method Validation for ISO 17025 and GLP/GMP Compliance
    Plenary Lecture
    Analytica Vietnam, Hanoi
  • March 17, 2009
    Compliance in Pharmaceutical Laboratories
    Discussion Forum
    Institute for Drug Quality Control (IDQC), Ho Chi Minh City, Vietnam

  • March 13, 2009
    Half Day Seminar and Discussion Forum: 3 topics
    Traceability in Laboratories for FDA and ISO17025 Compliance
    Cost Effective Management of Analytical Equipment
    Auditing Laboratories for FDA and ISO 17025 Compliance

    Ministry of Public Health

  • March 5, 2009
    Measurement Uncertainty in Chemical Analysis
    With tools to comply with ISO17025 Standard and FDA expectations
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • February 12, 2009
    Validation and Use of Excel® Spreadsheets in Regulated Environments
    Comply with GxPs, Part11, HIPAA, SOX and other regulations.
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • February 5, 2009
    Requirement Management for Equipment and Computer Systems
    Strategies for Development, Documentation and Updating Requirement Specifications
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • Jan 29/30, 2008, Heidelberg, Germany (in German)
    Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs (in German)
    Ludwig Huber: two presentations
    Validation and Qualification of Computer Systems
    Analytical Equipment Qualification


  • Jan 21/22, San Juan, Puerto Rico, USA
    Validation and Part 11 Compliance for (Bio)pharmaceutical and Device Industry
    Two day workshop with Dr. Ludwig Huber

  • January 9, 2009
    Master Planning for Software and Computer Validation
    With examples for master plan and several project plans
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

Presentations in 2008

  • Dec 11, 2008
    Auditing Computer Systems for FDA and EU Compliance
    For Validation and Part 11 Compliance in Pharmaceutical and Device Industries
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room
  • Dec 4, 2008
    Effective Gap Analysis for ISO 17025
    With Practical Tools for Easy Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room
  • Nov 13, 2008
    Raw Data in FDA Regulated Environments
    FDA/EU compliant recording, maintenance and archiving
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • Nov 06, 2008
    Bioanalytical Method Validation  (208)
    Conduct and Document for Efficiency and FDA and EMEA compliance
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • Oct 23, 2008
    Validation of Existing/Legacy Systems (207)
    Regulatory requirements and tools for implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • Oct 16, 2008
    Residual Solvent Analysis According to USP <467> (206)
    Understanding and implementing the revised chapter
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • September 27, Shanghai, China
    Compliance Workflow in Laboratories  
    Comply with FDA and other regulations from sampling to archiving of results
    2 hours Workshop at the Agilent VIP 

  • September 24/25, Shanghai, China
    2 Day Workshop at Analytica, China
    Ludwig Huber - Validation in Analytical Laboratories for FDA Compliance
    Day 1: Validation and Compliance Overview
    Day 2: Validation of Analytical Instruments and Computer systems

  • September 24, Shanghai, China
    Analytica, China - Plenary Lecture
    Ludwig Huber - Analytical Instrument Qualification According USP <1058>
    Introduction, Update and Strategies for Implementation

  • Sep 18, 2008
    Test Scripts and Protocols for Equipment and Computer Validation (205)
    With SOPs , examples scripts and protocols for FDA and EMEA compliance
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • Sept 4, 2008
    Effective Training Practices for FDA Compliance (204)
    What to train - How much to Train - How to Document Effectiveness
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • July 31, 2008
    FDA Globalization Act of 2008: More Fees, More Inspections (203)
    Understanding the impact on domestic and international companies
    Take Advantage of New Recommendations from FDA, EU Annex 11 and GAMP® 5
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • July 24, 2008
    Cost Effective Software and Computer System Validation (202)
    Take Advantage of New Recommendations from FDA, EU Annex 11 and GAMP® 5
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • July 16, 2008
    Why do We Have Regulations in Phama
    What are benefits for industry? How vendors support with regulation/compliance
    Ludwig Huber, Dinner Speech
    The Agilent Pharmaceutical Executive Dinner Party, Bangkok, Thailand

  • July 14 and July 16, BKK  and Hoh Chi Min City - Vietnam
    Agilent Compliance Seminar
    Ludwig Huber - Plenary Lecture
    Method Validation Requirements from the USP and FDA
    Impact on Pharmaceutical Analysis

  • July 11, 2008, Mumbai - India
    Agilent VIP Dinner with Keynote Presentation
    Ludwig Huber - Keynote presentation
    FDA Globalization Act of 2008
    New fees, more inspections, more documentation

  • July 7-10, 2008, Bangalore, Hyderabad, Ahmadabad, Mumbai - India
    Agilent Compliance Seminar
    Ludwig Huber - Plenary Lecture
    Method Validation Requirements from the USP and FDA
    Impact on Pharmaceutical Analysis
  • July 2, 2008
    FDA/EU cGMP Compliance for Laboratories (200)
    Requirements and Tools for Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • June 26, 2008
    Writing Effective SOPs For Regulatory Compliance (198)
    Content, format, approval, training and distribution
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • June 20 and June 22, 2008, Osaka, Tokyo, Japan,
    Agilent Compliance Seminar
    Ludwig Huber - Plenary Lecture
    Analytical Instrument Qualification (USP <1058>)
    Implementing the Final Release

  • June 20 and June 22, 2008, Osaka, Tokyo, Japan,
    Agilent Compliance Seminar
    Ludwig Huber - Plenary Lecture
    Impact of GAMP® 5 on Validation of Laboratory Computer Systems

  • June 11, 2008
    Contingency and Disaster Recovery Planning for Computer Systems (197)
    To Ensure Business Continuity and Compliance
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • May 29, 2008
    Development and Validation of Stability Indicating Methods (196)
    General Chapters, General Notices, Monographs, Forum, Reference Standards
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • May 20, 2008
    Sampling and Sample Handling in Laboratories (195)
    Strategies for  FDA and ISO 17025 Compliance and Tools for Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • May 12--14, 2008, New Jersey. USA
    I3 Day Workshop it
    All Workshops delivered Ludwig Huber 
    FDA Compliant Configuration Management and Change Control for Computer Systems
    Changes of Hardware, Firmware, Software, Networks, Documentation

  • May 8, 2008
    Understanding and Implementing the New EU Annex 11 (199)
    Learn about specific requirements and get tools for implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • May 1, 2008, Baltimore. USA
    IVT Conference - Computer System Validation
    Plenary Lecture -  
    FDA Compliant Configuration Management and Change Control for Computer Systems
    Changes of Hardware, Firmware, Software, Networks, Documentation

  • April 30, 2008, Baltimore. USA
    IVT Conference - Computer System Validation
    Plenary Lecture -  
    Learning from Recent FDA Warning Letters Related to Computer System Validation and Part 11
    With Clear Recommendations for Corrective and Preventive Actions

  • April 29, 2008, Baltimore. USA
    IVT Conference - Laboratory Controls and Compliance
    Plenary Lecture -  
    System Suitability Testing in Compendial Chromatographic Methods
    Understanding and Implementing Recent Changes of USP and EP

  • April 29 - May 2, 2008, Baltimore. USA
    IVT Conference - Laboratory Controls and Compliance
    Ludwig Huber - 90 min Interactive Session
    Understanding and Implementing Analytical Instrument Qualification According to USP
     
  • April 15, 2008
    Selection and Use of (Certified) Reference Material (194)
    Strategies for  FDA and ISO 17025 Compliance and Tools for Implementation
    Learn from your desk or in your seminar room

  • April 3, 2008
    Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 (193)
    With Clear Recommendations for Corrective and Preventive Actions
    Learn from your desk or in your seminar room

  • March 27, 2008
    Understanding the New USP <1058> for Analytical Instrument Qualification (192)
    Strategies for  FDA and ISO 17025 Compliance and Tools for Implementation
    Learn from your desk or in your seminar room

  • March 13, 2008
    Understanding USP Documents and Reference Standards (191)
    General Chapters, General Notices, Monographs, Forum, Reference Standards
    Learn from your desk or in your seminar room

  • February 28, 2008
    Validation of Analytical Methods and Procedures (190)
    Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025 Compliance
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • February 14, 2008
    Understanding and Implementing ISO 17025
    Requirements, Strategies and and Tool Kits for Laboratory Accreditation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • February 7, 2008, 2007
    Validation and Use of Excel® Spreadsheets in Regulated Environments
    Comply with GxPs, Part11, HIPAA, SOX and other regulations.
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • January 30, 2008, 2007
    FDA Requirements for Marketing Pharmaceutical Products in the United States
    Presentation and Round Table Discussion, Stuttgart, Germany

  • Jan 29/30, 2008, Heidelberg, Germany (in German)
    Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs (in German)
    Ludwig Huber: two presentations
    Validation and Qualification of Computer Systems
    Analytical Equipment Qualification

  • January 10, 2008, 2007
    System Suitability in Chromatographic Compendial Methods
    Understanding and Implementing Recent Changes of USP and EP
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

Presentations in 2007

  • December 6, 2007
    Laboratory Failure Investigations, OOS and CAPA
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • Dec 1/2, 2007, Beijing, China
    Ludwig Huber - 2 Day Workshop
    Equipment Qualification and Computer System Validation in Analytical Laboratories
    - Day 1: Calibration and Qualification of Equipment
    - Day 2: Practical Computer System Validation and Part 11 Compliance
     
  • Nov 13, 2007, Tokyo, Japan
    Annual Japan PDA Conference
    Ludwig Huber - Plenary lecture
    Implementation of Electronic Records and Signatures in Europe

  • Nov 12, 2007, Tokyo, Japan
    Japan PDA ERES Task Force Meeting
    Ludwig Huber - Plenary lecture and interactive discussion
    FDA Update on Electronic Records - Regulation, Guidance, Enforcement

  • November 8, 2007
    Cost Effective Electronic Archiving for FDA Compliance Recorded - CD Available
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • Nov 2, 2007, Hyderabad, India
    Seminar at Dr. Reddys
    Ludwig Huber - Interactive Discussion
    Implementing the New 21 CFR Part 11 for Pharmaceutical Development and Manufacturing

  • Nov 2, 2007, Hyderabad, India
    Seminar at Matrix
    Ludwig Huber - Interactive Discussion
    Practical Computer System Validation and Part11 Compliance

  • Nov 1, 2007, Hyderabad, India
    Anakon
    Ludwig Huber - Plenary Lecture
    Implementing USP <1058> for Analytical Instrument Qualification

  • Oct 30, 2007, Amman, Jordan
    USP Conference
    Ludwig Huber - Verification of Compendial Procedures
    FDA Compliance and Recommendations for Implementation

  • October 25, 2007
    Validation of Chromatographic Data Systems Recorded - CD Available
    - With Validation Examples from Planning to System Retirement -
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • October 18, 2007
    Electronic Audit Trail for FDA Compliance Recorded - CD Available
    Requirements - Implementation - Validation - Documentation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • Oct 23, 2007, Basel, Switzerland
    Agilent Compliance Seminar
    Ludwig Huber - Plenary Lecture
    Preparing Your Organization for the New Part11

  • Oct 2-5, 2007, San Diego, CA, USA
    IVT Conference -Laboratory Controls and Compliance
    Ludwig Huber - 3 hours workshop
    Rawdata in the Laboratory: Definition, Maintenance, Archiving

  • Oct 2-5, 2007, San Diego, CA, USA
    IVT Conference - Laboratory Controls and Compliance
    Ludwig Huber - Plenary Lecture
    Applying Risk Management to the Verification of Standard Methods

  • Oct 1-4, 2007, San Diego, CA, USA
    IVT Conference - Computer System Validation
    Ludwig Huber - 90 Min interactive discussion session
    Implementing the New 21 CFR Part 11 for Pharmaceutical Development and Manufacturing

  • Oct 1-4, 2007, San Diego, CA, USA
    IVT Conference - Computer System Validation
    Ludwig Huber - Half day pre-conference workshop
    Using Computers in Clinical Trials

  • Oct 1-4, 2007, San Diego, CA, USA
    IVT Conference - Computer System Validation
    Ludwig Huber - Plenary Lecture
    Strategies for Implementing the New Part 11

  • Sept 27, 2007
    Documentation for FDA Compliance Recorded - CD Available
    Step-by-step Instructions with Sample Documents
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • Sept 26, 2007, Berlin Germany
    Agilent Informatics Users Meeting
    Ludwig Huber - Workshop
    Electronic Raw Data - Definition, Generation, Processing, Archiving

  • Sept 25, 2007, Berlin Germany
    Agilent Informatics Users Meeting
    Ludwig Huber - Plenary Lecture
    Implementing FDA's Part 11

  • Sep 17-21, 2007, Tokyo and Osaka, Japan
    Agilent Compliance Seminar
    Ludwig Huber - Plenary Lecture
    Preparing Your Organization for the New Part11

  • Sep 15-17, 2007, Singapore, Kuala Lumpur (Malaysia)
    Agilent Compliance Seminar
    Ludwig Huber - Plenary Lecture
    Preparing Your Organization for the New Part11

  • Sept 5, 2007
    Using the Internet and Intranet in Regulated Environments
    Recorded - CD Available
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • August 9, 2007
    Good Laboratory Practice Regulations Recorded - CD Available
    Introduction and strategies for implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • July 26, 2007
    Transfer of Analytical Methods and Procedures
    FDA Requirements, Strategies and Tools for Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • July 18, Singapore
    HP Asia Pacific Pharmaceutical View Forum
    Risk Based Computer Validation for Highest Efficiency and FDA Compliance
    Ludwig Huber - Plenary Lecture

  • July 12, 2007
    Risk Based Computer Validation for Highest Efficiency and FDA Compliance CD Available
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • July 11, 2007
    Verification of Compendial Methods
    Understanding the New USP Chapter<1226>
    ComplianceOnline Web Seminar

  • June 28, 2007
    Implementing FDA's 'New' 21 CFR Part 11 CD Available
    Strategies and 10 Case Studies from Manufacturing, Offices and Laboratories
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • June 25, 2007, Heidelberg, Germany
    2nd European GMP Conference
    Process Validation: The New Validation Approach
    From 3 batches to continuous validation
    Chairman of 3 half day workshop
    European Compliance Academy

  • June 20, 2007
    Analytical Instrument Qualification (USP <1058>)
    Recommendations for Implementation
    Video Web Seminar with Ludwig Huber
    Learn from your desk or in your seminar room

  • June 14, 2007
    Network and IT Infrastructure Qualification CD Available
    Introduction and Strategies for Compliance and System Uptime
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • June 6, 2007
    Using Computerized Systems in Clinical Trials CD Available
    Understanding FDA's New Approach Towards Computer Systems
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • May 31, 2007
    Using Electronic Raw Data in FDA Regulated Environments CD Available
    Effective writing, implementation, reviews and updates
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • May 14-18, 2007, 5 City Tour, India
    Agilent Compliance Seminar
    Ludwig Huber - Plenary Lecture
    Preparing Your Organization for the New Part11

  • May 10, 2007
    Verification of Compendial Methods CD Available
    Understanding the New USP Chapter<1226>
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • May 3, 2007
    Retirement of Computer Systems CD Available
    Strategies for FDA Compliance and Tools for Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • April 24-26, 2007, Alexandria, VA, USA
    IVT Conference - Computer System Validation
    Ludwig Huber - 90 Min interactive discussion session
    Implementing the New 21 CFR Part 11 for Pharmaceutical Development and Manufacturing

  • April 24-26, 2007, Alexandria, VA, USA
    IVT Conference - Computer System Validation
    Ludwig Huber - Plenary Lecture
    Electronic Raw Data – Definition, Recording, Maintenance, Archiving

  • April 24-26, 2007, Alexandria, VA, USA
    IVT Conference - Computer System Validation
    Ludwig Huber - Plenary Lecture
    Strategies for Implementing the New Part 11

  • April 19, 2007
    Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control CD Available
    Comply with the most recent FDA Guideline
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • April 5, 2007
    How to Comply with International GMP Regulations CD Available
    Prepare Your API&Pharmaceutical Manufacturing for FDA/EU/Japan/TGA/WHO Inspections
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • April 3/4, 2007, Istanbul, Turkey
    Academia Life Sciences Centre
    Ludwig Huber - Two day seminar
    Equipment Qualification and Computer Validation in Laboratories

  • March 26-30, 2007, 5 City Tour, United States
    Agilent Compliance Seminar
    Ludwig Huber - Plenary Lecture
    Preparing Your Organization for the New Part11

  • March 22, 2007
    Computer System Validation for GLP CD Available
    How much is enough?
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • March 21, 2007, Delhi, India
    ComplianceOnline one day seminar
    Ludwig Huber: Computer System Validation and Part 11 Compliance in Practice
    *** Learn through case studies and examples ***

    March 15,, 2007, Athens, GA, USA
    31st International GMP Conference
    Ludwig Huber, 1/2 day Tutorial: Risk Based Equipment Qualification and System Validation in Testing Laboratories

  • March 7/8,, 2007, Mannheim, Germany (in German)
    Concept-Heidelberg Seminar: Computer System Validation Conference(in German)
    Ludwig Huber: Long Term Archiving and Retrieval of Data

  • March 1, 2007
    Learning From Laboratory Related FDA Warning Letters CD Available
    Learn from mistakes others made and how to avoid them
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • Feb 15/16, 2007, Heidelberg, Germany
    APV Seminar: Network Infrastructure Qualification (in German)
    Ludwig Huber: Risk Assessment for Networks

  • Feb 14, 2007
    FDA Compliant Standard Operating Procedures (165) CD Available
    Effective writing, implementation, reviews and updates
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • February 13, 2007
    Validation and Part 11 Compliance of Excel
    Compliance Online Webinar - From your desk

  • Feb 8, 2007
    Configuration Management and Change Control of Computer Systems (164) CD Available
    Hardware - firmware - software - networks
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • Feb 7, 2007
    Risk Based Validation of Software and Computer Systems
    Optimize Your Resources and Comply with FDA Guidelines
    IVT Webseminar

  • Jan 24/25, 2007, Mannheim, Germany
    Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
    Ludwig Huber: three presentations
    1) FDA compliant RAW Data and other records
    2) Validation of Electronic Records Systems
    3) Case Studies: Definition and handling of raw data - Applications in manufacturing and laboratory control

  • Jan 24/25, 2007, Heidelberg, Germany (in German)
    Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs (in German)
    Ludwig Huber: two presentations
    Validation and Qualification of Computer Systems
    Analytical Equipment Qualification

  • January 23, 2006
    Analytical Instrument Qualification According to USP Chapter <1058> (163) CD Available
    Introduction, Update and Recommendations for Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • January 18, 2006
    Validation and Use of ExcelSpreadsheets in Regulated Environments (162) CD Available
    Requirements and Tools for Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

Presentations in 2006

  • December 14, 2006
    Risk Management for Laboratory Systems (160) CD Available
    Requirements and Tools for Implementation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • December 5-7, 2006, Amsterdam, The Netherlands
    IVT Conference
    Computer System Validation
    Ludwig Huber - Plenary Lecture
    Preparing Your Organization for the New Part11

  • December 5-7, 2006, Amsterdam, The Netherlands
    IVT Conference
    Computer System Validation
    Ludwig Huber - Half day workshop
    Validation of Laboratory Data Systems

  • December 5-7, 2006, Amsterdam, The Netherlands
    IVT Conference
    Equipment Qualification and System Validation
    Ludwig Huber - 90 minutes interactive discussion sessions
    Testing Laboratory Equipment for Operational Performance and Compliance

  • December 5-7, 2006, Amsterdam, The Netherlands
    IVT Conference
    Equipment Qualification and System Validation
    Ludwig Huber - Plenary Lecture
    Qualification of Automated Systems

  • December 1-3, 2006, Mumbai, India
    Indian Drug Pharmaceutical Conference
    Ludwig Huber - Plenary Lecture
    Preparing Your Organization for the New Part11

  • November 13-15, 2006, Tokyo, Japan
    PDA Asia Pacific Conference
    Ludwig Huber - Plenary Lecture
    Preparing Your Organization for the New Part11

  • November 19-10, 2006, San Diego, United States
    Agilent Informatics Users Meetings
    Ludwig Huber - Plenary Lecture and Interactive Workshop
    Preparing Your Organization for the New Part11

  • October 25, 2006, Boston, United States
    Agilent Compliance Seminar Series
    Ludwig Huber - Lecture
    Preparing Your Organization for the New Part11

  • October 25, 2006, Boston, United States
    Agilent Compliance Seminar Series
    Ludwig Huber - Lecture
    Analytical Instrument Qualification - Implementing the New USP Draft <1058>

  • November 7, 2006
    Managing Failure Investigations and OOS (161) CD Available
    Implementing the New FDA Guide
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • October 23, 2006
    Auditing Analytical Laboratories for FDA Compliance CD Available
    Preparation - conduct - follow up - documentation
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • October 19, 2006
    Raw Data in FDA/EU Regulated Environments CD Available
    Compliant recording, maintenance and archiving
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • October 3-5, 2006, Singapore
    IVT Validation and Compliance Summit
    Ludwig Huber - Half day workshop
    Risk Management for Laboratory Systems

  • October 3-5, 2006, Singapore
    IVT Validation and Compliance Summit
    Ludwig Huber - 90 minutes interactive discussion session
    Analytical Instrument Qualification
    Implementing the new USP Chapter <1058> and the GAMP Laboratory GuideRaw Data in FDA/EU Regulated Environments
    Compliant recording, maintenance and archiving

  • October 3-5, 2006, Singapore
    IVT Validation and Compliance Summit
    Ludwig Huber - 90 minutes interactive discussion session
    The Self Audit: Assessing the Lab for FDA Compliance

  • October 3-5, 2006, Singapore
    IVT Validation and Compliance Summit
    Ludwig Huber - 90 minutes interactive discussion session
    Successful FDA Inspections – Preparation – Conduct – Follow up

  • August 14-17, 2006, Airlington, USA
    IVT Conference: Computer System Validation
    Ludwig Huber - Plenary Lecture
    Preparing Your Organization for the New Part 11

  • August 14-17, 2006, Airlington, USA
    IVT Conference: Computer System Validation
    Ludwig Huber - Plenary Lecture
    Implemeting International Regulations and Guidelines for Electonic Records&Signatures

  • August 14-17, 2006, Alexadria, USA
    IVT Conference: Computer System Validation
    Ludwig Huber - Half Day workshop
    Validation of Laboratory Data Systems

  • August 14-17, 2006, Alexadria, USA
    IVT Conference: Laboratory Regulations, Controls and Compliance
    Ludwig Huber - Plenary Lecture
    New Guidelines for Validation of Lab Equipment

  • August 14-17, 2006, Alexadria, USA
    IVT Conference: Laboratory Regulations, Controls and Compliance
    Ludwig Huber - Half Day workshop
    Validation of Automated Equipment

  • July 27, 2006
    Using the Intranet in Regulated Environments CD Available
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • July 13, 2006
    Increasing Productivity with Electronic Laboratory Notebooks CD Available
    Selection, Implementation and Strategies for Compliance
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • June 29, 2006
    Preparing Your Organization for the 'NEW' Part 11 (152) CD Available
    Learn What's Coming and How to Implement
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • June 22, 2006
    Using the SAFE Standard for Digital Signatures CD Available
    For legally enforceable IP Protection, Electronic Transactions and FDA Submissions
    Labcompliance Audio Seminar: Chairman Ludwig Huber
    Learn from your desk or in your seminar room

  • June 8, 2006
    Effective GxP Training Practices CD Available
    Optimize Your Resources and Comply with FDA Guidelines
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • June 7, 2006
    Using Excel in Regulated Environments
    FDA Info - Expert Briefing - From your desk

  • June 2, 2006, Prague
    The Fifth European Analytical Manager's Association Conference (EuroALMA)
    Plenary Lecture
    New Regulations and Guidelines for Analytical Laboratories

  • May 31, 2006
    Risk Based Validation of Software and Computer Systems CD Available
    Optimize Your Resources and Comply with FDA Guidelines
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • May 30, 2006, Cologne
    PIC/S Inspector Meeting (Expert Circle)
    Presentation and discussion: Ludwig Huber
    Trends in QC Laboratories

  • May 18, 2006
    Network Qualification CD Available
    Understanding the New GAMP/ISPE, IVT and FDA Guides
    Learn from your desk or in your seminar room

  • May 17, 2006
    Change Control for Software and Computer Systems
    ComplianceOnline Webinar - From your desk

  • May 4, 2006, Singapore
    One day Agilent seminar, three presentations
    * Electronic Raw Data in Regulated Environments - Definition, Maintenance, Archiving
    * Understanding the New GAMP and USP Guides for Laboratory Equipment Qualification
    * Introducing the New PIC/S Guide for Inspection of pharmaceutical Quality Control Laboratories .


  • May 3, 2006, Bangkok, Thailand
    One day Agilent seminar, three presentations/workshops
    * Electronic Raw Data in Regulated Environments - Definition, Maintenance, Archiving
    * Understanding the New GAMP and USP Guides for Laboratory Equipment Qualificaction
    * The New PIC/S guide for Inspection of pharmaceutical Quality Control Laboratories .


  • May 2, 2006, Kuala Lumpur, Malaysia
    One day Agilent seminar, three presentations/workshops
    * Electronic Raw Data in Regulated Environments - Definition, Maintenance, Archiving
    * Understanding the New GAMP and USP Guides for Laboratory Equipment Qualification
    * Introducing the New PIC/S Guide for Inspection of pharmaceutical Quality Control Laboratories .


  • April 27, 2006 Jinan, China
    One day Agilent seminar, three presentations
    * Impact of FDA's Quality System Guide on Laboratories
    * Risk Based Validation and Part 11 Compliance for Laboratory Systems
    * System Based Inspections – Laboratory Control Systems.


  • April 26, 2006, Beijing China
    Current Good Manufacturing Practices
    ISPE/US-FDA GMP Industry Training at University of Beijing
    Panel discussion: Joe Famulare, Erik Henrikson, Nick Buhay (US FDA, Office of Compliance) and Ludwig Huber (Labcompliance)

  • April 25, 2006, Beijing China
    Lab Validation
    ISPE/US-FDA GMP Industry Training at University of Beijing
    Joint Workshop: Nick Buhay (US FDA) and Ludwig Huber (Labcompliance)

  • April 20, 2006
    Developing a Validation Master Plan for Pharmaceutical Manufacturing CD Available
    Chairman: Ludwig Huber
    Presenter: Gabriela Bodea, Consultant
    Learn from your desk or in your seminar room

  • April 18, 2006
    Validation and Use of MS Access Databases in GxP and Part11 Environments CD Available
    Chairman: Ludwig Huber
    Presenter: Tyson M. Mew, President of Ofni Systems Inc
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • April 11, 2006
    Documentation for GxP Compliance CD Available
    Requirements from US FDA, Europe, PIC/S, WHO
    Labcompliance Audio Seminar
    Learn from your desk or in your seminar room

  • April 4-7, 2006, London, UK
    IVT Conference: Laboratory Controls and Compliance
    Ludwig Huber - Plenary Lecture
    Risk Management for Laboratory Systems

  • April 4-7, 2006, London, UK
    IVT Conference: Laboratory Controls and Compliance
    Ludwig Huber - 90 min interactive discussion session
    Implementing the New GAMP Guide for Validation of Laboratory Computer Systems

  • April 4-7, 2006, London, UK
    IVT Conference: Laboratory Controls and Compliance
    Ludwig Huber - 180 min workshop
    Implementing Analytical Instrument Qualification According to the New USP Draft <1058>

  • April 4-7, 2006, London, UK
    IVT Conference: Laboratory Controls and Compliance
    Ludwig Huber - Plenary Lecture
    New Guidelines for Validation of Lab Equipment

  • March 30, 2006
    Labcompliance Audio Seminar
    Validation of Analytical Methods and Procedures CD Available
    Learn from your desk or in your seminar room

  • March 29, 2006
    Analytical Instrument Qualification
    Compliance Online Webinar - From your desk

  • March 23, 2006
    Validation of Automated Laboratory Systems CD Available
    Learn from your desk or in your seminar room

  • March 22, 2006
    Analytical Instrument Qualification
    ComplianceOnline Web seminar - From your desk

  • March 14/17, 2006, Amsterdam, The Netherlands
    IVT Conference: Electronic Records Management
    Ludwig Huber - 90 minutes interactive session
    Managing 'Open Systems' for Compliance

  • March 14/17, 2006, Amsterdam, The Netherlands
    IVT Conference: Electronic Records Management
    Ludwig Huber - Plenary lecture
    Managing Electronic Records&Signatures for Global Compliance

  • March 14/17, 2006, Amsterdam, The Netherlands
    IVT Conference: Electronic Records Management
    Ludwig Huber - Half day workshop
    Implementing Risk Based Approaches for Electronic Records and Signatures

  • March 8, 2006, Copenhagen, Denmark
    Using Excel in Regulated Environments
    Interactive discussion session: ECA conference: Recent FDA/EU Requirements for Laboratory Computers and Records

  • March 8, 2006, Copenhagen, Denmark
    Update on FDA Requirements for Laboratory Computers and Records
    Plenary lecture: ECA conference: Recent FDA/EU Requirements for Laboratory Computers and Records

  • March 8, 2006, Copenhagen, Denmark
    Implementing the New GAMP Guide on the Validation of Laboratory Computerized Systems
    Half day workshop at the: ECA conference: Recent FDA/EU Requirements for Laboratory Computers and Records

  • March 7, 2006, Copenhagen, Denmark
    Qualification Requirements from Laboratory Systems to the IT Infrastructure
    Plenary lecture: ECA IT Infrastructure Conference

  • March 6, 2006, Copenhagen, Denmark
    Qualification of Network Infrastructure
    Half Day Preconference Workshop at the ECA IT Infrastructure Conference

  • March 2, 2006
    Labcompliance Audio Seminar
    Master Planning for Computer System Validation CD Available
    Learn from your desk or in your seminar room

  • March 1, 2006
    Computer System Validation - Introduction and Strategies for Implementation
    IVT Tele seminar - From your desk

  • February 22, 2006
    Validation and Part 11 Compliance of Excel
    Compliance Online Webinar - From your desk

  • February 22, 2006
    Analytical Instrument Qualification
    IVT Tele seminar - From your desk

  • February 14, 2006, Mannheim, Germany
    Validation of Laboratory Computer Systems (in German)
    Plenary Lecture at the ECA Computer Validation Conference: Agencies meet industry

  • February 2, 2006
    Labcompliance Audio Seminar
    Change Control for Computer Systems CD Available
    Learn from your desk or in your seminar room

  • Jan 25/26, 2006, Heidelberg, Germany (in German)
    Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs (in German)
    Ludwig Huber: two presentations
    Validation and Qualification of Computer Systems (in German)

  • January 19, 2006
    Labcompliance Audio Seminar
    FDA Compliant Testing for Validation and Qualification CD Available
    Learn from your desk or in your seminar room

  • January, 2006
    Analytical Instrument Qualification
    IVT Tele seminar - From your desk

Presentations in 2005 and before


December 8, 2005
Labcompliance Audio Seminar
Validation of Configurable Off-the-shelf Computer Systems CD Available
Learn from your desk or in your seminar room

December 2, 2005, Hyderabad, India
Recent Developments in US-FDA and International GxP Regulations and Guidelines
Plenary Lecture at the Indian Pharmaceutical Congress 2005

November 30, Ahmedabad, India
One day Agilent seminar, three presentations
* Introduction and Update to Regulatory Requirements for cGMP and GCP
* Risk Based Approach to implementation of 21 CFR Part 11 in Pharmaceutical Laboratories
* An introduction to Instrument and Software Validation in the Pharma Lab:- How to avoid an FDA Warning Letter

November 17, 2005
Labcompliance Audio Seminar
FDA/EU Compliance in Analytical Laboratories CD Available
Learn from your desk or in your seminar room

November 16, 2005
Agilent Web Seminar
Electronic Rawdata in FDA Regulated Environments
Definition, maintenance, archiving, retrieval-
At your desk or in a seminar room

November 8, 2005, Baltimoore
Electronic Rawdata in FDA Regulated Environments
- Definition, maintenance, archiving, retrieval -
Agilent Informatics Users Meeting

November 3 2005
Labcompliance Audio Seminar
FDA Compliant Electronic Records Management CD Available
Learn from your desk or in your seminar room

October 28, 2005, Shijiaozhuang, China
Half Day Seminar
FDA Inspections of API Manufacturers
Key methods for optimal preparation, conducts, and follow-up
Agilent Compliance Seminar Series

October 26, 2005, Shanghai, China
Latest Updates on FDA's 21 CFR Part 11 - Electronic Records and Electronic Signatures
Plenary Lecture
ChinaPharm 2005 Conference

October 25, 2005, Shanghai, China
GMP and GLP Difference Between FDA/EU and China
Plenary Lecture
ChinaPharm 2005 Conference

October 20, 2005
Labcompliance Audio Seminar
Using Excel in Regulated Environments CD Available
Validation, Part 11 Compliance, Documentation
Learn from your desk or in your seminar room

October 7, 2005
Barnett Web Conference
Risk Based System Inspections
Key methods for optimal preparation, conducts, and follow-up
At your desk or in your seminar room

October 6, 2005
Labcompliance Audio Seminar
Strategies for an Effective Root Cause Analysis and CAPA Program CD Available
Gabriela Bodea presenting, Ludwig Huber moderating
Learn from your desk or in your seminar room

October 4, 2005
IVT Tele Seminar
Electronic Rawdata in FDA Regulated Environments
- Definition, maintenance, archiving, retrieval -
At your desk or in a seminar room

September 28 , 2005, Dublin, Ireland
Half Day Seminar
1) Electronic Rawdata in FDA Regulated Environments
Definition, maintenance, archiving, retrieval
2) Validation of Computerized Laboratory Systems
Implementing the new GAMP Laboratory Systems Guide
Agilent Compliance Seminar Series

September 26/28 , 2005, Dublin, Ireland
IVT Conference: Laboratory Controls and Compliance
Ludwig Huber - 90 minutes interactive discussion session
Using Excel Spreadsheets in FDA/EU Regulated Environment

September 26/28 , 2005, Dublin, Ireland
IVT Conference: E-records/signatures and computer validation
Ludwig Huber - Half Day Workshop
Validating Configurable Off-The-Shelf (COTS) Software

September 26/28 , 2005, Dublin, Ireland
IVT Conference: E-records/signatures and computer validation
Ludwig Huber - Half Day Workshop
User Requirement Specifications for Computer Systems

September 22, 2005
Labcompliance Audio Seminar
Analytical Instrument Qualification (AIQ) CD Available
Understanding the New USP Draft Guidance <1058>
Learn from your desk or in your seminar room

September 19 2005
Agilent Web Seminar
Risk Based Computer Validation and Part 11 Compliance
At your desk or in your seminar room

September 8, 2005
Labcompliance Audio Seminar
Managing Failure Investigations and OOS Situations CD Available
Regulatory Requirements and Strategies for Implementation
Learn from your desk or in your seminar room

September 7, 2005
Agilent Web Seminar
Validation of Computerized Laboratory Systems
Implementing the new GAMP Laboratory Systems Guide
At your desk or in a seminar room

Juli 27, 2005
Labcompliance Audio Seminar
Risk Management for FDA/EU Regulated Industries CD Available
Introduction and Strategies for Compliance and Troublefree Operations
Learn from your desk or in your seminar room

July 19-22, 2005, Philadelphia, PA
IVT Electronic Laboratory Notebooks Conference
Half min interactive session
FDA Requirements for Electronic Records and Signatures

July 19-22, 2005, Philadelphia, NJ
IVT Electronic Laboratory Notebooks Conference
Half-day workshop
Validation of Electronic Laboratory Notebooks for FDA Compliance

Juli 7, 2005
Labcompliance Audio Seminar
Validation of Computerized Laboratory Systems CD Available
Implementing the new GAMP Laboratory Systems Guide
Learn from your desk or in your seminar room

June 27-30, 2005, Dublin Ireland
European Validation Week
Plenary lecture
Global Validation Requirements

June 27-30, 2005, Dublin Ireland
Risk Assessment Conference
90 min Interactive Session
Conducting Risk-Based Validation of Software and Computer System

June 27-30, 2005, Dublin Ireland
Risk Assessment Conference
Plenary Lecture
Reducing Validation Costs through Risk Assessment

June 27-30, 2005, Dublin Ireland
Risk Assessment Conference
Half-day workshop
Risk Assessment in Analytical Laboratories

June 23, 2005
Labcompliance Audio Seminar
Electronic Rawdata in FDA Regulated Environments CD Available
Learn from your desk or in your seminar room

June 9, 2005
Labcompliance Audio Seminar
21 CFR Part 11: Electronic Records and Signatures CD Available
Introduction and Strategies for Cost-effective Compliance
Learn from your desk or in your seminar room

May 13, 2005
Labcompliance Audio Seminar
User Requirement Specifications for Software and Computer Systems CD Available
Strategies for Development, Documentation and Maintenance
Learn from your desk or in your seminar room

April 25-28, 2005, Washington DC
IVT Conference: Laboratory Controls and Compliance
Ludwig Huber - 90 minutes interactive discussion session
Using Excel Spreadsheets in FDA/EU Regulated Environment

April 25-28, 2005, Washington DC
IVT Conference: E-records/signatures and computer validation
Ludwig Huber - Half Day Workshop
Validating Configurable Off-The-Shelf (COTS) Software

April 25-28, 2005, Washington DC
IVT Conference: E-records/signatures and computer validation
Ludwig Huber - Half Day Workshop
User Requirement Specifications for Computer Systems

April 25-28, 2005, Washington DC
IVT Conference: E-records/signatures and computer validation
Ludwig Huber - Plenary lecture:
The Top 10 Worst Computer Validation Mistakes to Commit

April 21, 2005
Labcompliance Audio Seminar
Network Infrastructure Qualification CD Available
Introduction and Strategies for Compliance and System Uptime
Learn from your desk or in your seminar room

April 19, 2005
Agilent Web Seminar
Pharmaceutical cGMPs for the 21st Century
At your desk or in a seminar room

April 16, 2005, Heidelberg, Germany
Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
Ludwig Huber: three presentations
1) FDA compliant RAW Data and other records
2) Validation of Electronic Records Systems
3) Case Studies: Definition and handling of raw data - Applications in manufacturing and laboratory control

April 11-14, Dublin, Ireland
IVT Conference: Laboratory Controls and Compliance
Ludwig Huber - Plenary lecture:
Impact of FDA's Quality System Guide on Laboratories

April 11-14, Dublin, Ireland
IVT Conference: Laboratory Controls and Compliance
Ludwig Huber - Half Day Workshop
Risk Based Validation and Part 11 Compliance for Laboratory Systems

April 11-14, Dublin, Ireland
IVT Conference: Laboratory Controls and Compliance
Ludwig Huber - Half Day Workshop
Configuration Management and Change Control for Laboratory Equipment and Computers

April 4-7, Washington D.C., US
IVT Conference: FDA Inspections
Ludwig Huber - 90 minutes interactive discussion session
Handling OOS Results; Managing Deviations

April 4-7, Washington D.C., US
IVT Conference: FDA Inspections
Ludwig Huber - Half Day Workshop
System Based Inspections – Quality Systems

April 4-7, Washington D.C., US
IVT Conference: FDA Inspections
Ludwig Huber - Half Day Workshop
System Based Inspections – Laboratory Control Systems

March 23, 2005
Labcompliance Audio Seminar
The Top 10 Worst Computer Validation Mistakes You can Make
Plus Strategies and Tools how to Avoid Them
Learn from your desk or in your seminar room

March 10, 2005
Labcompliance Audio Seminar
Managing Out of Specification Situations and Corrective/Preventive Actions CD Available
Learn from your desk or in your seminar room

February 21, 2005
Labcompliance Audio Seminar
How to Assess Suppliers of Software and Computer Systems CD Available
And reduce validation costs through supplier audits
Learn from your desk or in your seminar room

February 10, 2005
Labcompliance Audio Seminar
How to Comply with International GMP Regulations and Guidelines CD Available
Learn from your desk or in your seminar room

February 9, 2005
IVT Telseminar
Introduction to Computer Validation
Key Aspects of a Computer Validation Program –
Regulatory Expectations and Strategies for Implementation

Jan 27, 2005, Heidelberg, Germany (in German)
Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs (in German)
Ludwig Huber: two presentations
Validation and Qualification of Analytical Equipment
Validation and Qualification of Computer Systems

January 19, 2005
Labcompliance Audio Seminar
Using Internet and Intranet in Regulated Environments CD Available
Learn from your desk or in your seminar room

January 5, 2005
Labcompliance Audio Seminar
Eight Steps for Successful Software and Computer Validation CD Available
Learn from your desk or in your seminar room

Presentations in 2004 and before


December 9, 2004
Labcompliance Audio Seminar
Validation and Use of Excel Spreadsheets in GxP and Part 11 Environments CD Available
Learn from your desk or in your seminar room

December 1, 2004, Shanghai, China
One day Agilent seminar, three presentations
* National and International GMP Regulations and Guidelines
* Validation and Compliance in Pharmaceutical Laboratories
* Inspection of Pharmaceutical Laboratories


November 24, 2004, Mumbai, India
Plenary lecture Anakon-Analytica 2004
* New FDA Directions for Part 11 Compliance and Computer Validation


November 23, 2004, Mumbai, India
One day Agilent seminar, three presentations
* New FDA Directions for Part 11 Compliance and Computer Validation
* FDA Inspection and Enforcement Practices for Analytical Equipment, Computer Systems and Networks
* Validation of Analytical Methods


November 17, 2004, Heidelberg, Germany
Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
Ludwig Huber: three presentations
1) FDA compliant RAW Data and other records
2) Validation of Electronic Records Systems
3) Case Studies: Definition and handling of raw data - Applications in manufacturing and laboratory control

November 9, Tokyo, Japan
Annual PDA Conference 2004
PDA Japan
Plenary lecture - Most Recent Updates for Part 11 and Recommendations for Implementation

November 3, 2004
Labcompliance Audio Seminar
Strategies to Implement FDA's New Quality System Guide CD Available
Learn from your desk or in your seminar room

October 26, 2004, Barcelona, Spain
FDA/EU Requirements for Laboratory Computers and Records
European Compliance Academy
Plenary lecture - Compliance of Network Infrastructure and Systems

October 25, 2004, Barcelona, Spain
Update on FDA Requirements for Electronic records/signatures
European Compliance Academy
Plenary lecture - Update on FDA Requirements for Laboratory Computers

October 25, 2004, Barcelona, Spain
FDA/EU Requirements for Laboratory Computers and Records
European Compliance Academy
Pre-conference Workshop - Validation and Part 11 Compliance for Laboratory Computers

October 19, 2004, Philadelphia, PA, USA
IVT Conference: Network Qualification
Half day workshop: Configuration Management and Change Control for Networks

October 19, 2004, Philadelphia, PA, USA
IVT Conference: Network Qualification
Plenary lecture: FDA Requirements for Networks

October 18, 2004, Philadelphia, PA, USA
IVT Conference: Network Qualification
Half day workshop: Introduction to 21 CFR Part 11 and FDA's New Approach

October 6, 2004
Labcompliance Audio Seminar
Audits of Computer Systems in Laboratories and Manufacturing CD Available
Learn from your desk or in your seminar room

Sep 26/29, 2004, Dublin, Ireland
IVT Conference: E-records/signatures and computer validation
Plenary lecture:
Strategies to Define Part 11 Scope and Controls

Sep 26/29, 2004, Dublin, Ireland
IVT Conference: E-records/signatures and computer validation
90 min Interactive discussion session:
My Computer System is High, Medium or Low Risk. What does this mean?

Sep 26/29, 2004, Dublin, Ireland
IVT Conference: E-records/signatures and computer validation
Half day Workshop: Change Control and Configuration Management for Computer Systems

September 23, 2004
Video Web Seminar
Strategies for Risk Based Laboratory System Validation

September 21, 2004
APV Seminar on IT Infrastructure Qualification
Risk Management for Networks

September 14, Denver, USA
Risk Based Computer Validation FDA's Initiatives for the 21st Century
Agilent ChemStation Plus Users Meeting

September 2, 2004
Labcompliance Audio Seminar
Writing Effective Test Scripts and Validation Protocols for the Bio/Pharmaceutical Industry CD Available
Learn from your desk or in your seminar room

August 18, 2004, Philadelphia, US
Laboratory Controls & Compliance
IVT Conference
Discussion session: Implementing International Regulations and Quality Standards

August 4 2004
Labcompliance Audio Seminar
Laboratory Equipment Qualification CD Available
Learn from your desk or in your seminar room

July 29, San Juan, PR, USA
College of Chemists - Annual Symposium
Cost Effective Validation of Software, Computer Systems, and Networks in Analytical Laboratories

July 29, San Juan, PR, USA
College of Chemists - Annual Symposium
Validation and Qualification in Analytical Laboratories

July 27, 2004
In house seminar - Pfizer Barceloneta
Update on FDA's Drug GMP Initiative and 21 CFR Part 11

July 27, 2004
In house seminar - Pfizer Barceloneta
Risk Based Validation of Software and Computer Systems

July 22, 2004
Labcompliance Audio Seminar
Master Planning for Computer Validation CD Available
Learn from your desk or in your seminar room

July 14, 2004
Labcompliance Audio Seminar
Writing Effective SOPs for the Healthcare Industry CD Available
Learn from your desk or in your seminar room

July 13, 2004
IVT Teleseminar
Ludwig Huber
Quo Vadis - Where is the FDA going with Part 11?

June 17, 2004
Labcompliance Audio Seminar
Successful FDA Inspections - Preparation, Conduct, Follow Up CD Available
Learn from your desk or in your seminar room

June 15, 2004
Ranbaxy Global Management Meeting - London
FDA's New Approach for Quality Systems and Risk Based Compliance

June 3, 2004
Labcompliance Audio Seminar
Configuration Management and Change Control of Computer Systems CD Available
Learn from your desk or in your seminar room

May 27, 2004
Labcompliance Audio Seminar
Risk Based Computer Validation and Part 11 Compliance CD Available
Learn from your desk or in your seminar room

May 26, 2004, Karlsruhe, Germany (in German)
PCS Seminar: Using Excel in GMP Environment
Ludwig .Huber, EU and FDA GMP Requirements for MS Excel

May 24, 2004, Toronto, Canada
ASQ Annual Meeting
Ludwig Huber: plenary lecture
Risk Management For Regulated Software and Computer Systems

May 23, 2004, Toronto, Canada
ASQ Annual Meeting
Ludwig Huber: Full day workshop
Applying Risk Management to Computer Systems: Case Studies in Biomedical and Pharmaceuticals

May 13, 2004, Heidelberg, Germany
Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
Ludwig Huber: three presentations
1) FDA compliant RAW Data and other records
2) Validation of Electronic Records Systems
3) Case Studies: Definition and handling of raw data - Applications in manufacturing and laboratory control

May 3/6, 2004, Washington DC
IVT Conference: E-records/signatures and computer validation
Ludwig Huber - Plenary lecture:
Strategies to Define Part 11 Scope and Controls

May 3/6, 2004, Washington DC
IVT Conference: E-records/signatures and computer validation
Ludwig Huber - 90 min Interactive discussion session:
My Computer System is High, Medium or Low Risk. What does this mean?

May 3/6, 2004, Washington DC
IVT Conference: E-records/signatures and computer validation
Ludwig Huber - Half day Workshop: Change Control and Configuration Management

April 29, 2004
Labcompliance Audio Seminar
Effective Training for FDA Compliance CD Available
Learn from your desk or in your seminar room

April 22, 2004
Labcompliance Audio Seminar
Validation of Software and Computer Systems in Analytical Laboratories CD Availablee
Learn from your desk or in your seminar room

April 8, 2004
IVT Teleseminar
Ludwig Huber
Risk Based Validation of Computer Systems

March 29, 2004, Amsterdam, The Netherlands
Laboratory Controls & Compliance
IVT Conference
Ludwig Huber: Plenary lecture: The New Part 11 Guidance and its Effect on the Laboratory

March 29, 2004, Amsterdam, The Netherlands
Laboratory Controls & Compliance
IVT Conference
Ludwig Huber: Workshop: Implementing Part 11 in Analytical Laboratories

March 25, 2004
Labcompliance Audio Seminar
Validation of Spreadsheets for Part11 and GxP Compliance CD Available
Learn from your desk or in your seminar room

March 23, 2004
Labcompliance Audio Seminar

FDA's 21 CFR Part 11

Requirements, New Scope and Recommendations for Implementation CD Available
Learn from your desk or in your seminar room

Feb 26, 2004, Singapore
GxP Week of IQPC
90 min Spotlight Session
How to Avoid FDA Inspection Observations and Warning Letters

Feb 25, 2004, Singapore
GxP Week of IQPC
90 min Spotlight Session
Validation of Computerized Systems and Software in Analytical Laboratories

February 19, 2004
Labcompliance Audio Seminar
Part 11 Case Studies CD Available
The Ultimate Answers and Tools You Need to Define and Document Your Part 11 Scope and Controls
Learn from your desk or in your seminar room

Feb 3/5, 2004, Amsterdam, The Netherlands
IVT Conference: Network Infrastructure Qualification and System Validation
Ludwig Huber: four presentations
1) Plenary lecture: FDA Requirements for Computer Systems, Networks, and IT Infrastructure
2) Interactive discussion session:
How to Avoid 483’s and Warning Letters Relating to Network Qualifications
3) Workshop: Keeping Networks 21 CFR Part 11 Compliant
4) Interactive discussion session: Developing test scripts and other Documentation for Infrastructure Qualification

Feb 2/5, 2004, Amsterdam, The Netherlands
IVT Conference: Validation Week
Ludwig Huber: three presentations
1) Plenary lecture: Pharmaceutical cGMP's for the 221st Century
2) Workshop: Navigating FDA's New Part 11 Guidance
3) Discussion session: Managing international laboratory compliance

Jan 28/29, 2004, Heidelberg, Germany (in German)
Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs (in German)
Ludwig Huber: two presentations
Validation and Qualification of Analytical Equipment
Validation and Qualification of Computer Systems

Jan 27, 2004, Worldwide, Teleseminar
Strategies to Define Part 11 Scope and Controls
IVT

January 15, 2004
Labcompliance Audio Seminar
Using Excel in GxP/Part11 Environment CD Available
Learn from your desk or in your seminar room

Presentations in 2003 and before


December 19, 2003, Chennai, India
Annual Indian Pharmaceutical Congress (IPC)
Ludwig Huber: Plenary lecture
Recent GxP Initiatives in Europe and United States

December 18/19, 2003, Mumbai/Chennai, India
One day Agilent seminar
Risk Management for GxP and Part 11 Compliance

Dec 16, 2003, Darmstadt, Germany
Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
Ludwig Huber: three presentations
1) FDA compliant RAW Data and other records
2) Change of data - audit trail
3) Definition and handling of raw data: Applications in manufacturing and laboratory control

December 11, 2003
Labcompliance Audio Seminar
Cost effective Strategies for Network Compliance and System Uptime
Learn from your desk or in your seminar room CD Available

Nov 19, 2003, Worldwide, Teleseminar
Strategies to Optimize Costs vs. Risks for FDA's New Part 11 Guidance
IVT, CD available

Nov 19, 2003, Karlsruhe, Germany (in German)
PCS Seminar: Using Word Processors and Docment Management Systems in GMP Environment
Ludwig .Huber, EU and FDA GMP Requirements for Word Processors and Document Management Systems

Nov 18, 2003, Karlsruhe, Germany (in German)
PCS Seminar: Using Excel in GMP Environment
Ludwig .Huber, EU and FDA GMP Requirements for MS Excel

November 17/18
Advanced Computer System Validation
SMI
Ludwig Huber: Plenary lecture - New Regulations and Guidance for Computer Systems: E-records/signatures

October 31, 2003, Beijing, China
Invited by the China FDA Headquarter for Half Day Seminar and Round Table Discussion
Ludwig Huber: Worldwide Trends in Compliance for the Pharmaceutical Industry

October 30, 2003, Beijing, China
Invited by Beijing's Science and Technology Commission for
Half Day Seminar and Round Table Discussion
Ludwig Huber: Worldwide Trends in Compliance for the Pharmaceutical Industry

October 29, 2003, Tokyo, Japan
Annual PDA Conference 2003
PDA Japan
Ludwig Huber: Plenary lecture - Risk Assessment for Part 11 and GxP Compliance

October 27 and 28, 2003, Agilent Technologies
Half day seminar series
October 27, Osaka, Japan
October 28, Tokyo, Japan

Recent regulations/guidelines, inspection and enforcement trends for pharmaceutical laboratories

EU and US-FDA requirements for computer systems and e-records

Risk assessment for GxP and part11 compliance

Oct 6/8, Philadelphia
IVT Conference: Network Infrastructure Qualification and System Validation
Ludwig Huber: three presentations
1) Plenary lecture: FDA Requirements for Computer Systems, Networks, and IT Infrastructure
2) Interactive discussion session:
How to Avoid 483’s and Warning Letters Relating to Network Qualifications
3) Workshop: Keeping Networks 21 CFR Part 11 Compliant

October 1/2, 2003, Mannheim, Germany
FDA Conference 2003
European Compliance Academy
Ludwig Huber: Plenary lecture - New Directions for Part 11 - What's Next?

September 18, 2003, Vienna, Austria
FDA/EU Requirements for Laboratory Computers and Records
European Compliance Academy
Ludwig Huber: Plenary lecture - Compliance of Network Infrastructure and Systems

September 17, 2003, Vienna, Austria
Update on FDA Requirements for Electronic records/signatures
European Compliance Academy
Ludwig Huber: Plenary lecture - Update on FDA Requirements for Laboratories

September 17, 2003, Vienna, Austria
FDA/EU Requirements for Laboratory Computers and Records
European Compliance Academy
Ludwig Huber: Pre-conference Workshop - Meeting FDA requirements for Electronic Records

September 16, 2003, Brussels, Belgium
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Using the Internet in part 11 environment
Half day workshop

September 16, 2003, Brussels, Belgium
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Lifecycle Planning for Software and Computer Validation
Half day workshop

September 15, 2003, Brussels, Belgium
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Impact of FDA's news risk based system inspections on part 11 and computer validation
Plenary lecture

August 19, 2003, Short Hills, NJ, USA
Laboratory Controls & Compliance
IVT Conference
Ludwig Huber: Plenary lecture: The New Part 11 Guidance and its Effect on the Laboratory

Sep 12, 2003, Worldwide, Teleseminar
Implementing FDA's New Part 11 Final Guidance: Scope and Applications
IVT

August 18, 2003, Short Hills, NJ, USA
Laboratory Controls & Compliance
IVT Conference
Ludwig Huber: Workshop: Implementing Part 11 in Analytical Laboratories

August 14, 2003, San Francisco, CA, USA
IVT : International Seminar Series
Ludwig Huber: Network Infrastructure Qualification & System Validation
Full day workshop

August, 2003, Agilent Technologies
Half day seminar series
August 11: Indianapolis, ID
August 12: Chicago, IL
August 13: West Lake Village, CA
August 13: Anaheim, CA
August 15: San Francisco

Recent regulations/guidelines, inspection and enforcement trends for pharmaceutical laboratories
The New Part 11 Guidance and Its Affect on the Laboratory
E-records/signatures: Validation of Computer Systems according to new FDA and EU guidelines Qualification of Network Infrastructure and Validation of Networked Data Systems

July 16, 2003, San Juan, Puerto Rico, Agilent Technologies Seminar
Half day seminar
Recent regulations/guidelines, inspection and enforcement trends for pharmaceutical laboratories

The New Part 11 Guidance and Its Affect on the Laboratory
E-records/signatures: Validation of Computer Systems according to new FDA and EU guidelines
Validation of Network Data Systems for Part 11 Environment

July 1, 2003, Brussels, Belgium
Barnett Conference: Network Infrastructure Qualification & System Validation
Ludwig Huber: Develop solutions for network configuration management and change control

June 30, 2003, Bruessel, Belgium
Barnett Conference: Network Infrastructure Qualification & System Validation
Ludwig Huber: Using the Internet in a Regulated Environment

May 22, 2003, Karlsruhe, Germany (in German)
PCS Seminar: Using Excel in GMP Environment
Ludwig .Huber, EU and FDA GMP Requirements for MS Excel

May 21, 2003, Worldwide, Teleseminar
Impact on FDA's New Risk Based Approach on Part 11
IVT

May 21, 2003, Karlsruhe, Germany
PCS Seminar: Using Access in GMP Environment (in German)
Ludwig .Huber, EU and FDA GMP Requirements for MS Access

May 20, 2003, Karlsruhe, Germany (in German)
PCS Seminar: Using Word Processors and Docment Management Systems in GMP Environment
Ludwig .Huber, EU and FDA GMP Requirements for Word Processors and Document Management Systems

May 14, 2003, Orlando, FL, USA
FDA's Science and Risk Based GMP Inspections -
What does this mean for laboratories?
at the Agilent Technologies Networked Data Systems Users Meeting
Plenary lecture

May 13, 2003, Orlando, FL, USA
Impact of FDA's New Part 11 Guidance on Laboratories
at the Agilent Technologies Networked Data Systems Users Meeting
Half day workshop

May 12, 2003, Philadelphia, PA, USA,Park Hyatt
Develop Strategies for Converting to a Paperless Laboratory while Remaining in Complaince with FDA/EU Guidelines
at the Barnett conference : Laboratory Controls

May 12, 2003, Philadelphia, PA, USA,Park Hyatt
Understanding FDA Inspection trends for Laboratory Control
at the Barnett conference : Laboratory Controls

May 2, 2003, Chicago, USA
Impact of FDA's part 11 new guidance document on analytical laboratories
at the IIR conference : Laboratory Equipment Validation&Calibration
Plenary lecture

May 1, 2003, Chicago, USA
Impact of FDA's new Initiative on drug quality to laboratory equipment and part 11 compliance
at the IIR conference : Laboratory Equipment Validation&Calibration
Plenary lecture

April 30, 2003, Washington, USA
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Using the Internet in part 11 environment
Half day workshop

April 29, 2003, Washington, USA
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Using macros and spreadsheets in a regulated environment
Half day workshop

April 28, 2003, Washington, USA
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Impact of FDA's news risk based system inspections on part 11 and computer validation
Plenary lecture

April 16 and 17,2003: Internet Seminar
Design Qualification and Re-qualification
Attendees should have a good understanding on basics of computer validation and 21 CFR Part 11. As pre-study material attendees can order free literature from the LabCompliance literature service.

Mar 04, 2003, New Dehli, Mar 05, Ahmedabad, Mar 06, Chennai
Agilent Technologies Asian Compliance Seminar Tour
One day seminars in three Indian cities:

Complying with International Regulations in the Pharmaceutical Industry

FDA and international regulations/guidelines for pharmaceutical development and QA

Validation of computer systems in laboratories

Electronic records/signature and 21 CFR Part 11 compliance

Analytical method validation

Feb 27, 2003, Tokyo, Japan
PDA Japan: 21 CFR Part 11 Task Force Meeting
Ludwig Huber, 4 presentations

FDA Update on 21 CFR Part 11

FDA's cGMP Initiative for science and risk based inspections: impact on part 11 and computer validation

API and 21 CFR Part 11

The impact of the part 11 guide 'Scope and Application' on chromatographic data systems

Feb 26, 2003, Tokyo, Japan
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Developing an Effective 21 CFR Part 11 Training Program Supporting Regulatory Compliance

Feb 26, 2003, Tokyo, Japan
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Using the Internet in a Part 11 Regulated Environment

Feb 26, 2003, Tokyo, Japan
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Using Macros and Spreadsheets in Regulated Environment

Feb 25, 2003, Tokyo, Japan
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Qualification of network infrastructure and validation of networked systems

Feb 24, 2003, Tokyo, Japan
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
How to Apply FDA's Recent Part 11 Interpretations and Industry Guidances to Laboratory Computers

Feb 10/11, 2003, Philadelphia, Hyatt Hotel, PA, USA
Barnell Conference: Network Infrastructure Qualification & System Validation
Ludwig Huber: Develop solutions for network configuration management and change control

Jan 27/29, 2003
IVT Conference: Network Infrastructure Qualification and System Validation
Ludwig Huber: two presentations
1) Using the Internet in a Regulated Environment
2) Validation of Networked Systems

Jan 20, 2003, Singapore, Jan 22, Gouangzhou, Jan 23 Shanghai, Jan 24, Beijing
Agilent Technologies Asian Compliance Seminar Tour
One day seminars in four Asian cities:
Complying with International Standards in the Pharmaceutical Industry
FDA and international regulations/guidelines for pharmaceutical development and QA
Validation of computer systems in laboratories
Electronic records/signature and 21 CFR Part 11 compliance
How an instrument vendor can help with compliance (by Yoko Gemba, YAN Japan)

Jan 20, 2003, Singapore, Jan 22 Guangzhou China, Jan 23 Shanghai, Jan 24 Beijing
Agilent Technologies Asian Compliance Seminar Tour
One day seminars in four Asian cities:
Complying with International Standards in the Pharmaceutical Industry
FDA and international regulations/guidelines for pharmaceutical development and QA
Validation of computer systems in alboratories
Electronic records/signatures and 21 CFR Part 11 compliance
How an instrument vendor can help with compliance
Demonstration of software that helps to comply with the most recent regulations

Jan 16/17, 2003, Heidelberg, Germany (in German)
Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs (in German)
Ludwig Huber: two presentations
Validation and Qualification of Analytical Equipment
Validation and Qualification of Computer Systems

Presentations in 2002 and before


Dec 9, 2002, Amsterdam, The Netherlands, Radison Hotel
IIR: Workshop, half day
Ludwig Huber
Using Networks in a Part 11 Regulated Environment
Radisson SAS - Amsterdam

Dec 9/12, 2002, Amsterdam, The Netherlands
IIR conference: Electronic Signatures and 21CFR Part 11 Compliance
Ludwig Huber
Presentation: Ensuring compliance of a vendor purchased system

December 2-3, 2002, Barcelona Spain
GMP-/FDA Compliant Raw Data Management and Archiving
ECA Conference (European Compliance Academy)
Ludwig Huber: two presentations
1) FDA compliant RAW Data and other records
2) Raw data in quality control

Nov 20, 2002, Copenhagen, Denmark
Concept Heidelberg: Workshop, half day
Ludwig Huber
Implementing FDA’s 21 CFR Part 11: Electronic Records and Signatures

Nov 20/21, 2002, Copenhagen, Denmark
Concept Heidelberg conference: European Part 11 Conference
Ludwig Huber: two presentations
Using Networks in a Part 11 Regulated Environment
Long Term Archiving and Ready Retrieval of Electronic Records
With Preconference Workshop: Introduction to 21 CFR Part 11 (Speaker: Ludwig Huber)

Nov 10/11, 2002, Cologne, Germany (in German)
Concept Heidelberg conference: German Part 11 Conference
Ludwig Huber: two presentations (in German)
Qualification and Validation of Networks and Applications
Long Term Archiving and Ready Retrieval of Electronic Records

November 14/14: Internet Seminar
Laboratory Compliance with FDA’s Part 11 e-Records Maintenance Guidance
Attendees should have a good understanding on basics of computer validation and 21 CFR Part 11. As pre-study material attendees can order free literature from the LabCompliance literature service.

Oct 24, 2002, Berlin, Germany
Nugenesis, User Conference 2002
Ludwig Huber: Moving to the Paperless Laboratory - Regulatory and Business Aspects

Oct 23, 2002, Darmstadt, Germany
Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
Ludwig Huber: three presentations
1) FDA compliant RAW Data and other records
2) Change of data - audit trail
3) Applications in quality control

Oct 7/8, Philadelphia
IVT Conference: Network Infrastructure Qualification
Ludwig Huber: two presentations
1) Using the Internet in a Regulated Environment
2) Validation of Networked Systems

October 2/4,
Ludwig Huber, Agilent Technologies
Latest FDA and European regulations, guidelines, inspection and enforcement practices for pharmaceutical laboratories
Computer validation including networked systems, 21 CFR Part 11, Method validation: supported by video clips with FDA speakers
Seminar with Ludwig Huber in East of United States and in Canada

Oct 1, Philadelphia
Pharmaceutical Education Associates (PEA): LabMation Conference
Ludwig Huber
Plenary Session: Latest FDA Regulations, Guidelines, Inspection and Enforcement Practices for Pharmaceutical Laboratories
Plenary lecture

Philadelphia, Sep 30 - Oct 2, 2002
Infrastructure Qualification and Network Validation
Center for Business Intelligence
Ludwig Huber: Regulatory Requirements for Change Management and Control

Sept 30, Philadelphia
Pharmaceutical Education Associates (PEA): LabMation Conference
Ludwig Huber
Design and Validation of Laboratory Computers and Data Systems for E-Records/E-Signature Compliance
Half day workshop

September 24, Dublin, Ireland
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
How to Apply FDA's Recent Part 11 Interpretations and Validation Guidance to Analytical Laboratory Computers
Half day interactive session

September 23, Dublin, Ireland
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Qualification of network infrastructure and validation of networked systems
Half day interactive session

September 23, Dublin, Ireland
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Using Macros and Spreadsheets in Regulated Environment
90 min Interactive session

June 13, Philadelphia, USA (full day)
LIMS 2002 Post Conference Workshop
Ludwig Huber
Implementing E-record&signature Compliance in Laboratory Data Systems and LIMS
One day Interactive session

June 10 - 19
Ludwig Huber, Agilent Technologies
Latest FDA regulations, guidelines, inspection and enforcement practices for pharmaceutical laboratories
Computer validation including networked systems, 21 CFR Part 11, Method validation: supported by video clips with FDA speakers
Seminars with Ludwig Huber North America

May 31, Brussels, Belgium
Ludwig Huber, Agilent Technologies
Laboratory Equipment Qualification
IVT

May 16, 2002, London, UK
IBC Conference: Validation of Computer Systems,
Using Macros and Spreadsheet programs in regulated environments

May 15, 2002, London, UK
IBC Conference: Validation of Computer Systems,
Validation and Qualification of Networks and Networked Systems

May 15, 2002, London, UK
IBC Conference: Validation of Computer Systems,
Operational Compliance for Legacy Systems

April 24, Washington, USA
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
How to Apply FDA's Recent Part 11 Interpretations and Validation Guidance to Analytical Laboratory Computers
Half day interactive session

April 24, Washington, USA
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Using Macros and Spreadsheets in Regulated Environment
90 min Interactive session

April 23, Washington, USA
IVT Conference: E-records/signatures and computer validation
Thomas Quinn and Ludwig Huber
Qualification of network infrastructure and validation of networked systems
Half day interactive session

April 10-12
Ludwig Huber, Agilent Technologies
Latest FDA and European regulations, guidelines, inspection and enforcement practices for pharmaceutical laboratories

Computer validation including networked systems

21 CFR Part 11,

Method validation

Seminar with Ludwig Huber in East of United States

April 9, 2002, Philadelphia, PA, USA
Laboratory Equipment Validation&Calibration Conference IIR,
Design and Validation of Chromatographic Data Systems for Compliance with 21 CFR Part 21 (Electronic records/signatures)

April 8, 2002, Philadelphia, PA, USA
Validation and Qualification of Computerized Analytical Systems
at the IIR conference : Laboratory Equipment Validation&Calibration
Half day pre-conference workshop

March 21, 2002, Darmstadt, Germany
Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
Ludwig Huber: three presentations
1) FDA compliant RAW Data and other records
2) Change of data - audit trail
3) Applications in quality control

March 11 to 15, 2002, India: Mumbai, Bangalore, Hyderabad
Ludwig Huber, Agilent Technologies
Latest FDA and European regulations, guidelines, inspection and enforcement practices for pharmaceutical laboratories
Overview: global regulations, Individual sessions on computer validation including networked systems, 21 CFR Part 11, Method validation: supported by video clips with FDA speakers
Three one day seminars with Ludwig Huber in Mumbai (11), Bangalore (13) and Hyderabad (15)

Mar 06, 2002, Berlin, Germany
Concept Heidelberg conference: Successful HPLC Management in a GMP-/FDA-Regulated Environment
Ludwig Huber: Regulatory requirements and enforcement practices for HPLC

Feb 22, 2002, Tsukuba, Japan
Agilent Seminar for Yamanouchi company: E-records/signatures/Validation
1) Qualifying network hardware and software in networked systems
2) Design and validate a chromatographic data system for compliance with 21 CFR Part 11: FDA's inspection findings, enforcement practices, and recommended responses for 21 CFR Part 11 in Chromatographic Data Systems

Feb 21, 2002, Tokyo, Japan
IVT Conference: E-records/signatures
Response of the Pharmaceutical Industry in Europe and in United States to 21 CFR Part 11

Feb 21, 2002, Tokyo, Japan
IVT Conference: E-records/signatures
Design and Validation of Chromatographic Data Systems for 21 CFR Part 11

Feb 20, 2002, Tokyo, Japan
IVT Conference: E-records/signatures
Understanding Recent Part 11 guidance documents

Feb 20, 2002, Tokyo, Japan
IVT Conference: E-records/signatures
Part 11 Compliance with Audit Trail Requirements of Part 11

Feb 19, 2001, Tokyo, Japan
IVT Conference: Validation of Software and Computer Systems,
Operational Compliance for Legacy Systems

Feb 19, 2002, Tokyo, Japan
IVT Conference: Validation of Software and Computer Systems,
Validation and Qualification of Networks and Networked Systems

February 15, 2002, London, UK
IBC conference: InfoTech Pharma 2002
Ludwig Huber: Key Note presentation
Update on regulations and guidelines in US and EU

February, March, April 2002: Internet Seminar Series
21 CFR Part 11 and Computer Validation
The FDA has published draft guidance document on validation for part 11. In addition, a lot of other papers have been published on 21 CFR part 11. In response to this Agilent Technologies will run a series of on-line seminars to discuss what these new documents mean for analytical laboratories. Seminars are scheduled for European and American time zones. The seminars are free.
The seminars will be developed and/or presented by Ludwig Huber.
For abstracts, dates and registrations click on the titles to visit the Agilent on-line seminar website
(EUROPE) Impact of FDA's 21CFR11 Validation Guidance on Pharmaceutical Laboratories
(AMERICA) Impact of FDA's Part 11 - Validation Guidance for Pharmaceutical Laboratories (AMERICA) Review of the latest Information on the Application and Enforcement of FDA 21CFR Part 11
(AMERICA) Complying with FDA 21CFR11 using Agilent's ChemStation Plus
(EUROPE) Review of the Latest Information on the Application and Enforcement of 21 CFR Part 11
Attendees should have a good understanding on basics of computer validation and 21 CFR Part 11. As pre-study material attendees can order free literature from the LabCompliance literature service.

January 15/16, 2002, Heidelberg, Germany
Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs (in German)
Ludwig Huber: two presentations
Validation and Qualification of Analytical Equipment
Validation and Qualification of Computer Systems

January 14 2002, London, UK
SMI conference: Laboratory Equipment Validation
Ludwig Huber:
Design and validation of chromatographic data systems

Presentations in 2001 and before

Dec 11, 2001, Heidelberg, Germany
Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
Ludwig Huber: three presentations
1) FDA compliant RAW Data and other records
2) Change of data - audit trail
3) Applications in quality control

Dec 4, 2001, Stuttgart, Germany
PCS Conference: Validation of Computerized Systems
Ludwig Huber: Validation of analytical systems and data evaluation software (in German)

Nov 14, 2001,
Ludwig Huber, Agilent Technologies
Application of Part 11 for selected computer systems in manufacturing and laboratories
Presented at Pharmacia-Upjohn, United States

Nov 5-14, 2001,
Ludwig Huber, Agilent Technologies
Latest FDA and European regulations, guidelines, inspection and enforcement practices for pharmaceutical laboratories
Computer validation including networked systems, 21 CFR Part 11, Method validation: supported by video clips with FDA speakers
Eight one day seminars with Ludwig Huber in California and Midwest, United States

Oct 23, 2001,
Co-sponsored by Agilent Technologies and Pharmaceutical Society Korea:
Latest regulations, guidelines, inspection and enforcement practices for the pharmaceutical laboratory
One day seminar with Ludwig Huber
For details: click here

Oct 17, 2001, Tokyo, Japan
IVT Conference: E-records/signatures
Part 11 Compliance with Audit Trail Requirements of Part 11

Oct 16, 2001, Tokyo, Japan
IVT Conference: Validation of Software and Computer Systems,
Operational Compliance for Legacy Systems

Oct 16, 2001, Tokyo, Japan (
IVT Conference: Validation of Software and Computer Systems,
Validation and Qualification of Networks and Networked Systems

Oct 15, 2001, Tokyo, Japan
IVT Conference: Laboratory Equipment Qualification and Validation,
Design and Validate a Chromatographic Data System for Compliance with FDA's 21 CFR Part 11

Sept 25-28, 2001,
Co-sponsored by Agilent Technologies, Pharmacia, AstraZeneca, Pharmaceutical Society Denmark:
Latest regulations, guidelines, inspection and enforcement practices for the pharmaceutical laboratory
Four one day seminars with Ludwig Huber in Finland, Schweden (2) and Denmark
For details: click here

Jul 24, 2001, Kuala Lumpur, Malaysia
Seminar cosponsored by the National Pharmaceutical Control Burea, the Ministry of Health Clinical Investigation Centre Malaysia, The University Malaya Medical Centre and Agilent Malaysia
Objectives and Trends for Quality Systems - CGMP/GLP/ISO17025

Jul 23, 2001, Singapore, Jul 25 Kuala Lumpur, Jul 27 Bangkok, Jul 31 Taipei, Aug 2 Beijing
Agilent Technologies Asian Compliance Seminar Tour
One day seminars in five Asian countries:
Implementing ISO 17025 and GLP/GMP in Analytical Laboratories
Overview of regulations and quality standards with impact on analytical laboratories
Validation and qualification of analytical equipment and computers
Validation of analytical methods: New ICH, USP, FDA guidelines

How to comply with most recent requirements of ISO 17025 and regulations:
e.g., measurement uncertainty, 21 CFR Part 11

Case studies using computerized HPLC equipment and methods as examples
July 24, 2001, Singapore, Agilent Technologies Seminar
Half day seminar
Recent regulations/guidelines, inspection and enforcement trends for pharmaceutical laboratories
Overview: new regulations, guidelines, US FDA's/EU inspection and enforcement practices, industry's response
E-records/signatures: FDA's 21 CFR Part 11, European initiatives
Validation of analytical equipment and computer systems
Validation of analytical methods: New ICH, USP, FDA guidelines

June 27, 2001, Orlando, FL
Agilent Technologies Networked Data Systems Users Meeting, Operational Compliance of Legacy Systems

June 27, 2001, Orlando, FL
Agilent Technologies Networked Data Systems Users Meeting, Update on compliance: new regulations, guidelines, inspection and enforcement practices in America and Europe

June 26, 2001, Philadelphia, PA, USA
Laboratory Equipment Validation&Calibration Conference IIR, Design and Validation of Chromatographic Data Systems for Compliance with 21 CFR Part 21 (Electronic records/signatures)

Users of chromatographic data systems experience specific problems with 21 CFR part 11 (electronic records and signatures). This presentation provides an overall strategy and specific examples on how to specify, install, validate and operate such systems in compliance with the rule. This presentation addresses the following topics:
Definition of raw data and meta data for signals and spectra
Recording and long-term archiving and ready retrieval of data including meta-data
Audit trails of multiple data reprocessing
Binding signatures with the electronic records
Log-on multiple users on PC controlled multi-instrument systems
Validation of hybrid chromatographic systems

June 25, 2001, Philadelphia, PA, USA
Half Day Preconference Workshop: Validation and Qualification of Computerized Analytical Systems, at the IIR conference : Laboratory Equipment Validation&Calibration

Using practical examples, this workshop guides QA and laboratory managers and users of computer controlled analytical instruments through the entire validation process, from design and vendor qualification, through installation qualification, operational qualification and performance qualification. It gives practical recommendations on how to speed up the validation processes and how to do it 'right' the first time, thus building confidence for audits and inspections and avoiding troublesome rework. This workshop provides clear step-by-step instructions on:
Developing a validation master plan
Developing user requirement and functional specifications (DQ)
Selecting and qualifying a vendor
Testing and documentation for installation and operational qualification (IQ,OQ)
Testing for on-going performance qualification (PQ)
Evaluation and validation of existing systems
Revalidation after hardware repair and after firmware and software updates
Validation of user contributed software, e.g., Macros
Validation for FDA's 21 CFR Part 11 compliance
Preparing for inspections
This workshop is designed for maximum interaction between the speakers and delegates. Delegates are strongly encouraged to participate in workshop discussions.


June 22, 2001, Philadelphia, PA, USA
Barnett International
Workshop: FDA Compliance for Computerized Spectroscopy Systems

Part 1. Validation of Computerized Spectroscopy Systems

Session Description:
While in the past the FDA was focusing more on inspection of equipment hardware and analytical methods, now they pay more attention on laboratory computer systems. Using specific case studies, this presentation will give an overall strategy but also focus on most critical points such as worst case testing and change control. Using examples from analytical laboratory with stand-alone and networked computer systems attendees will learn:
About recent FDA 483's and Warning letters for computer systems and laboratory networks
How to develop a validation strategy master plan
How to get the most help from suppliers
How to perform IQ/OQ/PQ most cost effectively
How to manage change control
Implementation for spectroscopy systems


June 22, 2001, Philadelphia, PA, USA
Barnett International
Workshop:FDA Compliance for Computerized Spectroscopy Systems
Part 2: Upgrading Spectroscopy Systems to FDA Part 11 Compliance

Users of computerized analytical systems experience specific problems with 21 CFR part 11 (electronic records and signatures). This presentation provides an overall strategy and specific examples for spectroscopy systems on how to specify, select, install, validate and operate such systems in compliance with the rule. This presentation addresses the following topics:
FDA's inspection and enforcement practices
Definition of raw data and meta data
Long-term archiving and ready retrieval of data including meta-data
How to comply with audit trail requirements
Strategy for existing spectroscopy systems
Gap analysis and implementation plan


May 31, 2001, Sidney, Australia
RACI PHARMACEUTICAL SCIENCE GROUP (NSW)
Method Development and HPLC Analytical Validations (including impurities)

May 31, 2001, Sidney, Australia
RACI PHARMACEUTICAL SCIENCE GROUP (NSW)
Analytical Instrumentation - Computer Validations and Security - CFR11 issues

May 29, 2001 and May 30, 2001 Melbourne, Australia
Agilent Technologies Australian Quality&Compliance Seminar Tour
Three half day seminars at Fauldings Pharmaceutical, Sigma and CSL

Implementing Quality and Compliance in Pharmaceutical Laboratories
Validation and qualification of analytical equipment and computers
Design and validation of chromatographic data systems for 21 CFR Part 11 compliance
Validation of analytical methods: New ICH, USP, FDA guidelines

May 28 2001, Brisbane, Australia
Agilent Technologies Australian Quality&Compliance Seminar Tour
Half day seminar
Implementing Quality and Compliance in Analytical Laboratories
Overview of regulations and quality standards with impact on analytical laboratories
GLP/GMP/ISO17025
Validation and qualification of analytical equipment and computers
Validation of analytical methods: New ICH, USP, FDA guidelines

May 24/25, 2001, London, UK
Institute of Validation and Technology
Two day conference, "Laboratory Equipment":
L.Huber, FDA Expectations for 21 CFR Part 11

April 26/27, 2001, Philadelphia, USA
May 24/25, 2001, London, UK
Institute of Validation and Technology
Two day conference, "Laboratory Equipment":
L.Huber, Validation of Computerized Systems & Laboratory Networks

While in the past the FDA was focusing more on inspection of equipment hardware and analytical methods, now they pay more attention on laboratory computer systems and most recently also on Networks. Using specific case studies, this presentation will give an overall strategy but also focus on most critical points such as worst case testing and change control. Using examples from analytical laboratory with stand-alone and networked computer systems attendees will learn:
About recent FDA 483's and Warning letters for computer systems and networks
How to develop a validation strategy master plan
How to get the most help from suppliers
How to perform IQ/OQ/PQ most cost effectively
What and how much to test on a network
How to manage change control

April 26/27, 2001, Philadelphia, USA
May 24/25, 2001, London, UK
Institute of Validation and Technology
Two day conference, "Laboratory Equipment":
L.Huber, GAMP Initiatives for Computerized Laboratory Systems

The Good Automated Manufacturing Practices (GAMP) Forum exists to promote the understanding of the regulation and use of computers within the pharmaceutical industry. The forum has done an excellent job on developing industry guidelines for software and computer validation. While FDA regulations say what to do, GAMP guidelines tell very much in detail on how to implement regulations and to reduce business risks. They are increasingly used throughout the world in preparation for regulatory inspections and for vendor audits. Currently there are three main (draft) documents available: Validation of Automated Systems, 21 CFR Part 11, and IT infrastructure quality. In addition there are special interest groups on selected topics, such as laboratory equipment. This presentation explains the key points of the documents from a practical view and how they can help to comply most effectively in laboratories.
Attendees will learn about:
GAMP initiatives and guidelines, where to get the documents
GAMP computer system classifications with examples from the laboratory
GAMP approach to successful and cost effective validation of automated systems
Using the GAMP approach to upgrade a laboratory to part 11
What can we learn from special interest groups

March 28/29, 2001, London, UK
Business Intelligence
Two day conference: Computer Systems Validation
L.Huber: Operational Compliance for Legacy Systems

Legacy systems are those that have been designed, developed and/or used before regulations have been in place or enforced. Compliance for them is more difficult than for new systems. Most important for legacy systems is to develop and implement a corrective action plan with time schedules, owners and checkpoints. . In this presentation we will cover:

FDA's enforcement practices for legacy systems, recent examples of inspectional observations and warning letters
Development of a compliance master plan for legacy systems
System inventories and gap analysis
Setting priorities based on impact on product quality and nature and extend of non-compliance
Development and implementing technical and procedural controls to comply with part 11
Steps for retrospective validation: Setting specifications, IQ, OQ
Effective change management

March 27, 2001, Cork, Ireland
Seminar at Pfizer
L.Huber, Comply with Audit Trail Requirements
Even though audit trail it self is nothing new for FDA regulated environments it is the most frequently discussed requirement of part 11. There are two reasons for this: 1. Missing software to meet the new requirement to generate the audit trail by the computer independently from the operator and 2) Uncertainty on when audit trail should start and what it should include.

Using practical examples from laboratories, production control and office area, attendees will learn:
FDA's requirements and enforcement practices
What should be included in the audit trail
The level of detail
When audit trail should start in a document development chain
How to link audit trails with other electronic records to ensure authenticity
What to do in case software providers do not offer audit trail functionality
User requirement and functional specifications for audit trails

March 27, 2001, Cork, Ireland
Seminar at Pfizer
L.Huber, 21 CFR Part 11, Basic requirements and impact on chromatographic data systems

March 27, 2001, Cork, Ireland
Seminar at Pfizer
L.Huber, Qualification of Networks and Validation on Networked Systems

March 27, 2001, Cork, Ireland
Seminar at Pfizer
L.Huber, Validation of computerized Analytical Ststems

March 6/7, 2001, Baden-Baden, Germany
Pharmaceutical Training Services
Two day conference, "Validation in Laboratories":
L.Huber, Half day workshop: Validation and qualification of equipment (in german)

Feb 21, 2001, London, USA
Institute of Validation and Technology
Two day conference, "Electronic Records and Signatures":
L.Huber, Comply with Audit Trail Requirements

Even though audit trail it self is nothing new for FDA regulated environments it is the most frequently discussed requirement of part 11. There are two reasons for this: 1. Missing software to meet the new requirement to generate the audit trail by the computer independently from the operator and 2) Uncertainty on when audit trail should start and what it should include.

Using practical examples from laboratories, production control and office area, attendees will learn:
FDA's requirements and enforcement practices
What should be included in the audit trail
The level of detail
When audit trail should start in a document development chain
How to link audit trails with other electronic records to ensure authenticity
What to do in case software providers do not offer audit trail functionality
User requirement and functional specifications for audit trails

Feb 21, 2001, London, USA
Institute of Validation and Technology
Two day conference, "Computer Validation":
L.Huber, Validation and Qualification of Databases and Networks

Most recently the FDA pays much attention to the validation of Networks in laboratories and production control. For example, in summer this year a five page 483 inspectional observation on missing or incomplete validation of a Local Area Network and a Wide Area Network has been issued by the FDA. Validation of networks is not only important to meet FDA requirements but to meet business requirements. For example, it can be a disaster for a company if complete databases are lost because of a non-validated back-up or disaster recovery procedure. On the other hand it is obvious that in a complex network not all possible combinations can be tested, so optimizing risk vs. cost is important.

Using a Laboratory Network as an example, attendees will learn
About FDA's inspectional observations on networks
How to get the most help from the supplier
What and how to test during installation and operation (IQ/OQ)
How to ensure on-going performance (PQ)
How to validate functions as required by 21 CFR part 11
Risk assessment versus costs, e.g., how many clients should be tested
Validating back-up and recovery procedures

Jan 30, 2001, Ulm, Germany
Merckle
L.Huber, Update on 21 CFR Part 11: FDA and Industry Initiatives

Jan 24, 2001, Washington, USA
Institute of Validation and Technology
Two day conference, "Electronic Records and Signatures":
L.Huber, Comply with Audit Trail Requirements

Jan 23, 2001, and Feb 20, 2001

Implementing 21 CFR Part 11 - An Overview w/ Recommendations for the Analytical Laboratory, Web seminar: Agilent Technologies

The FDA rule on electronic signatures and records has been in effect since 1997, but only recently have they been enforced. Although the rules are well documented, there is still confusion in regulated industry about implementation. This seminar, the first in a series of five, the series, will give overall strategies and practical examples for implementation in the chromatographic laboratory.

Jan 22, 2001, Washington, USA
Institute of Validation and Technology
Two day conference, "Computer Validation":
L.Huber, Validation and Qualification of Databases and Networks

January 16, 2001, Darmstadt, Germany
Validation and Qualification of Analytical Equipment (in German)
Validation and Qualification of Computer Systems (in German)
Qualification of HPLC and GC Systems (in German)
Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs

Presentations in 2000and before

 
November 13, 2000, San Diego, CA, USA
Laboratory Equipment Validation&Calibration Conference IIR, Design and Validation of Chromatographic Data Systems for Compliance with 21 CFR Part 21 (Electronic records/signatures)

November 14, 2000, San Diego, USA
Half Day Preconference Workshop: Validation and Qualification of Computerized Analytical Systems, at the IIR conference : Laboratory Equipment Validation&Calibration

Using practical examples, this workshop guides QA and laboratory managers and users of computer controlled analytical instruments through the entire validation process, from design and vendor qualification, through installation qualification, operational qualification and performance qualification. It gives practical recommendations on how to speed up the validation processes and how to do it 'right' the first time, thus building confidence for audits and inspections and avoiding troublesome rework. This workshop provides clear step-by-step instructions on:
Developing a validation master plan
Developing user requirement and functional specifications (DQ)
Selecting and qualifying a vendor
Testing and documentation for installation and operational qualification (IQ,OQ)
Testing for on-going performance qualification (PQ)
Evaluation and validation of existing systems
Revalidation after hardware repair and after firmware and software updates
Validation of user contributed software, e.g., Macros
Validation for FDA's 21 CFR Part 11 compliance
Preparing for inspections

This workshop is designed for maximum interaction between the speakers and delegates. Delegates are strongly encouraged to participate in workshop discussions.

Nov 9/10, 2000, Basel, Switzerland
L. Huber, Impact of Part 11 on Analytical Laboratories, AVP Symposium on Electronic Records/Signatures

Nov 15/16, London, United Kingdom
Moving LIMS from Handwritten Signatures to 21 CFR Part 11 Compliant E-signatures and E-records, EU LIMS 2000 Conference

Oct 27, 2000, Comply with 21 CFR Part 11, Web seminar: Agilent Technologies

Oct 23, 2000, Comply with 21 CFR Part 11, Web seminar: Agilent Technologies

Oct 16/18, 2000, Boston, USA
ISLAR, Data management / 21CFR Part 11 Session
L. Huber, Data Management and CFR 21 Part 11 for Networked Chromatography Data Systems

Oct 6, 2000, Copenhagen, Denmark
L. Huber, Developing an 'Active' Implementation Plan for Part 11

Oct 5, 2000, Copenhagen, Denmark
L. Huber, 21 CFR Part 11 - Three Years After Release, ECA Conference: FDA's 21 CFR Part 11 on E-Records/Signatures in Laboratories

Sept 28, 2000, Dublin, Ireland
Institute of Validation and Technology
Two day conference, "Laboratory Equipment/Instrumentation Validation":
L.Huber, Validation of Software and Computerized Analytical Systems

Sept 28, 2000, Dublin, Ireland
Institute of Validation and Technology
Two day conference, "Laboratory Equipment/Instrumentation Validation":
L.Huber, Review Validation Data and Documentation for Instrument/Equipment Validation

Sept 27, 2000, Dublin, Ireland
Institute of Validation and Technology
Two day conference, "Investigating OOS Test Results":
L.Huber, Avoiding Out-of-Specification Situations.

By far the best way to deal with OOS situations most effectively is to avoid them as much as possible. OOS can have two main reasons: uncontrolled production processes or raw materials and laboratory errors. This presentation demonstrates how OOS situations caused by laboratory errors can be minimized through tight control of the laboratory processes. Upcoming out of control situations can be predicted and therefore avoided by regular analysis of quality control samples and graphical evaluation of quality control samples. Parameters to be controlled and evaluated are not only sample amounts but much more the ones which most likely cause out of control situations. These can be critical instrument parameters or unstable consumables and maintenance parts. Other mechanisms to avoid OOS include early maintenance feed back systems (EMF) as built into the laboratory equipment.

Sept 26, 2000, Dublin, Ireland
Institute of Validation and Technology
Two day conference, "Electronic Records and Signatures: Case Study Forum":
L.Huber, Case study: Upgrading a pharmaceutical laboratory to part 11 compliance.

Sept 26, 2000, Dublin, Ireland
Institute of Validation and Technology
Two day conference, "Electronic Records and Signatures: Case Study Forum":
L.Huber, Data migration, long term archiving and ready retrieval.

Sept 19, 2000, Osaka and Sept 20, Tokyo, Japan
YAN-Agilent Compliance seminar
L.Huber, FDA's 21 CFR Part 11 on E-signatures/records - Three years after release.

Sept 19, 2000, Osaka, and Sept 20, Tokyo, Japan
YAN-Agilent Compliance seminar
L.Huber, Case study, Upgrading a Pharmaceutical Laboratory to Part 11 compliance

Sept 16, 2000, Mumbai, India
Indian Drug Manufacturers' Association (IDMA), Annual convention
L.Huber, Key Note address, US FDA and International Trends in GLP and GMP Regulations

Sept 15, 2000, Mumbai, India
Electronic Records and Signatures in Pharmaceutical Laboratories , Agilent Technologies,
Part of one day seminar: Recent developments in pharmaceutical regulations

Sept 15, 2000, Mumbai, India
Validation in Pharmaceutical Laboratories , Agilent Technologies,
Part of one day seminar: Recent developments in pharmaceutical regulations

Sept 15, 2000, Mumbai, India
Case study: Upgrading computerized pharmaceutical laboratory to GLP/GMP compliance, Agilent Technologies, Part of one day seminar: Recent developments in pharmaceutical regulations

Sept 15, 2000, Mumbai, India
International and US FDA trends in pharmaceutical GLP/GMP regulations, Agilent Technologies, Part of one day seminar: Recent developments in pharmaceutical regulations

Sept 13, 2000
One day conference, "Electronic Signatures in Europe", PTS, Mannheim, Germany
L.Huber, Electronic Signatures in Laboratories.

Sept 12, 2000, Comply with 21 CFR Part 11, Web seminar: Agilent Technologies

August 14/15, 2000, Washington D.C., USA
Institute of Validation and Technology
Two day conference, "Electronic Records and Signatures: Case Study Forum":
L.Huber, Case study: Upgrading a pharmaceutical laboratory to part 11 compliance.

August 14/15, 2000, Washington D.C., USA
Institute of Validation and Technology
Two day conference, "Electronic Records and Signatures: Case Study Forum":
L.Huber, Data migration and long term archiving for ready retrieval.

July 28, 2000, One Day Workshop at the at the Chulalongkorn University, Bangkok, Thailand
Validation Processes in Analytical Laboratories

July 27, 2000, One Day Workshop at the at the Chulalongkorn University, Bangkok, Thailand
Implementing Quality Assurance in Analytical Laboratories

July 26, 2000, Shanghai, China, Shanghai Drug Control
GLP and GMP in Analytical Laboratories , half day seminar

July 25, 2000, Shanghai, China, Hotel Sofietel
Electronic Records and Signatures in Pharmaceutical Laboratories , Agilent Technologies, Shanghai Branch, MNC Seminar

July 25, 2000, Shanghai, China, Hotel Sofietel
Validation in the pharmaceutical industry, Agilent Technologies, Shanghai Branch, MNC Seminar

July 25, 2000, Shanghai, China, Hotel Sofietel
Trends in pharmaceutical GLP/GMP regulations, Agilent Technologies, Shanghai Branch, MNC Seminar

July 17, 2000, Comply with 21 CFR Part 11, Technologies

July 11, 2000, Comply with 21 CFR Part 11, Web seminar: Agilent Technologies

July 5, 2000, London, UK
L. Huber, Vendor Contributions for Computer Validation, SMI Conference: The Validation of Corporate IT Systems in the Pharmaceutical Industry

July 5, 2000, Comply with 21 CFR Part 11, Web seminar: Agilent Technologies

July 4, 2000, Comply with 21 CFR Part 11, Web seminar: Agilent Technologies

June 30, 2000, Comply with 21 CFR Part 11, Web seminar: Agilent Technologies

June 28, 2000, Antwerp, Belgium
L. Huber, Vendor Contributions for 21 CFR Part 11, GAMP Forum

June 20, 2000, London, United Kingdom
IBC Conference on Computer Validation, 21 CFR Part 11: FDA's Recent Inspection and Enforcement Practices

June 13, 2000, San Juan, Puerto Rico
Laboratory Equipment Validation&Calibration Conference IIR, Design and Validation of Chromatographic Data Systems for Compliance with 21 CFR Part 21 (Electronic records/signatures)

June 12, 2000, San Juan, Puerto Rico
Half Day Preconference Workshop: Validation and Qualification of Computerized Analytical Systems, at the IIR conference : Laboratory Equipment Validation&Calibration

May 18, 2000, RTP, NC, USA
New Trends and Developments in Regulations HPLC for Pharmaceutical Industry, Dinner Presentation, Agilent Technologies, Raleigh NC

May 16, 2000, Atlantic City, USA
Moving LIMS from Handwritten Signatures to 21 CFR Part 11 Compliant E-signatures and E-records, LIMS 2000 Conference

May 11, 2000, Comply with 21 CFR Part 11, Web seminar: Agilent Technologies

May 10, 2000, Amsterdam, The Netherlands
Analytical Equipment Qualification as Prerequisite for Method Validation, APV Conference: Analytical Method Validation

April 27/28, 2000, Philadelphia, PA, USA
Two day conference, Electronic signatures and records, implementing part 11:
L.Huber, How to Deal with Chromatographic Hybrid Systems for Part 11.

Feb 16 to Mar 3, 2000, E-records and E-signatures Overview and Review of FDA Enforcement Trends

Feb 22/23, 2000, London, UK
Two day conference, Electronic signatures and records, implementing part 11:
How to Deal with Chromatographic Hybrid Systems for Part 11.

Feb 3, 2000, Bangkok, Thailand
Half Day Seminar, Implementing the new ISO 17025 Quality and Accreditation Standard in Analytical Laboratories

January 27/28, 2000, Singapore
L. Huber, US FDA and International Regulations and Guidelines for Analytical Laboratories: Update, Presented at Agilent Singapore

January 12, 2000, Darmstadt, Germany
Validation and Qualification of Analytical Equipment (in German)
Validation and Qualification of Computer Systems (in German)
Qualification of HPLC and GC Systems (in German)
Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs

Presentations in 1999 and before


November 29/30, London, UK
L.Huber, Moving from paper to compliant electronic signatures and records, LG/GC International, Spectroscopy and Scientific Data Management Conference on new applications for greater productivity in Quality Control etc.

December 17, 1999, London, UK (postponed until 2000)
L.Huber, Design of Analytical Equipment for Compliance, LGC Conference on Equipment Qualification

November 17-19, Dublin, Ireland
L.Huber, Requirements and Enforcement Practices of 21 CFR Part 11, presented at the Agilent Seminar "Implementing 21 CFR Part 11 for Chromatographic Data Systems"

November 11, Groton, Connecticut, USA
Seminar at Pfizer, Moving Chromatographic Data Systems from Paper to Electronic Records and Signatures
Part 1: Regulation and Enforcement Practices
Part 2. Understanding and Implementing Administrative and Technical Controls

November 8/10, Miami
Laboratory Equipment Validation&Calibration Conference IIR, L. Huber, Design and Validation of Chromatographic Data Systems for Compliance with 21 CFR Part 21 (Electronic records/signatures)

September 30, 1999, Toronto, Canada
Canadian Validation and Calibration Symposium, L.Huber, Validation of computer systems and software in analytical laboratories

September 22, 1999, Berlin, Germany
One day international seminar: FDA requirements to computers in analytical lab, including computer validation, electronic records, electronic signatures. 21CFR11, L. Huber chairman and main speaker: two presentations:
Update on regulations and FDA's inspection practices and Preparing inspection ready documentation (in German)

September 26/27, 1999, Mannheim, Germany
Validation in Analytical Laboratories, national conference, L.Huber
Validation of computer systems in analytical laboratories (in German)

August 26/27, 1999, Washington, United States
Two day conference, Electronic signatures and records: L.Huber, Workshop leader: how to deal with chromatographic hybrid systems

April 13 and April 15
Oaska and Toko, Japan
L.Huber, Implementing validation of standalone computer systems and networks, Developing a validation plan, writing a design qualification, , validating Vendors, IQ/OQ testing, performance qualification, retrospective validation of existing systems.

April 23, 1999
Taipei, Taiwan
1 day workshop Validation and qualification in analytical laboratories

April 19, Singapore
L.Huber, 21CFRPart 11, Electronic records and signatures: What does it mean for equipment and software vendors?

April 7, Basel, Switzerland
Novartis
L.Huber, half day seminar, Validation and qualification of analytical equipment and systems

April 28, Mannheim, Germany
Concept -Heidelberg
1 Day seminar: FDA requirements for Pharma QA/QC labs, L.Huber, Raw Data in Chromatography

May 19, 1999, Saarbruecken, Germany
1 day seminar
L.Huber, Validation of Computerized Analytical Systems
Seminar Klinkner&Partner

January 27, 1999, Weest, The Netherlands
L.Huber, Moving from paper to electronic records, 21 CFR Part 11 , Solvay seminar

January 27, 1999, Weest, The Netherlands
L.Huber, System life cycle, Solvay seminar

December 2, 1998, Darmstadt, Germany (in German)
L.Huber, One day seminar: FDA requirements to computers: regulations, validation, electronic signatures, data traceability and integrity, Concept Heidelberg

January 19, 1999, Darmstadt, Germany
L.Huber, The Role of the Vendor for Equipment Calibration and Qualification, Concept Heidelberg.

Presentations in 1998 and before

December 3, 1998, Berlin, Germany
L.Huber, Validation of Computer Systems in Analytical Laboratories, Seminar: Dr.Klinkner: Validation in Analytical Laboratories, Haus der Technik, in German.

March 19, 1998, Waldbronn, Germany
L.Huber, Laboratory accreditation: New ISO Guide 25 and its impact on analytical laboratories, Hewlett-Packard Seminar

February 10, 1998, Mannheim, Germany
L.Huber, Validation of LIMS, PTS LIMS Seminar.

February 17, 1998, Darmstadt, Germany
L.Huber, The Role of the Vendor in Equipment Qualification, Concept Heidelberg Seminar: Calibration and Qualification of Analytical Equipment

May 19, Saarbruecken Germany
L.Huber, Validation of Computerized Systems, One day seminar, Klinkner&Partner, in German.

May 14, 1998, Essen, Germany
L.Huber, Validation of Computer Systems in Analytical Laboratories, Seminar: Dr.Klinkner: Validation in Analytical Laboratories, Haus der Technik, in German.

May 5, 1998, Singapore
L. Huber, International Regulations and Quality Standards -
Impact on Analytical Laboratories,
Presented at a Hewlett-Packard Seminar

Presentations in 1997 and before


December 11, 1997, Darmstadt, Germany
L.Huber, Application of Computers in Regulated Environments, One day Seminar, Concept Heidelberg, in German.

November 25/26, 1997, Strasbourg, France
L.Huber, The Role of the Vendor for Equipment Calibration and Qualification, International Symposium on Equipment Calibration and Qualification, Concept Heidelberg.

November 20, 1997, Essen, Germany
L.Huber, Validation of Computer Systems in Analytical Laboratories, Seminar: Dr.Klinkner: Validation in Analytical Laboratories, Haus der Technik, in German.

November 3, 1997, San Jose, Costa Rica
L.Huber, Validation of analytical equipment and methods to meet GLP and GMP requirements in pharmaceutical laboratories, Pan American Pharmaceutical Symposium

November 5, 1997, Mexico City, Mexico
L.Huber, Validation of analytical equipment and methods, Hewlett-Packard Seminar

October 2, 1997, Toronto, Canada
L. Huber, System Validation and System Suitability Testing, Canadian Calibration and Validation Group: Annual Symposium 1997.

Oct 3, 1997,
L.Huber, Quality Assurance during software development GlaxoWellcome Seminar, Toronto Canada

September 23, 1997, Seoul, Korea
L. Huber, International Regulations and Quality Standards, National Korean GLP/GMP Symposium, Interface.

April 28/29, 1997, Moris Plaints, NJ, USA
L.Huber, The HP Chemical Analysis Group Software Quality System, Warner Lambert Computer Validation Symposium.

May 14/15, 1997, Berlin, Germany
L.Huber, Validation of Computer Systems in Analytical Laboratories, Seminar: Dr.Klinkner: Validation in Analytical Laboratories, Haus der Technik.

June 21/23, 1997, Buenos Aires, Argentina
L.Huber, Validating automated analytical equipment and methods, Second International Symposium of the Latin American and Caribbean Section of AOAC International.

June 24, 1997, Sao Paulo, Brazil
L.Huber, Establishing GLP and GMP Systems in a Laboratory, Hewlett-Packard Seminar.

June 25, 1997, Rio de Janeiro, Brazil
L.Huber, Easy and Trouble free Validation and Qualification of Analytical Equipment , Hewlett-Packard Seminar.

July 25, 1997, Konstanz, Germany
L.Huber, Validation of Computerized Analytical Systems, Byk Gulden Validation Seminar.

Presentations in 1996 and before


March 26 and May 29, 1996, Essen, Germany
L. Huber, The OECD Consensus paper - Applications of GLP to computerized Systems:
Responsibilities of Vendors, Presented at the Training for GLP Inspectors in Germany on "GLP and Electronic Data Handling"

October 21/22, 1996, London,
L. Huber, Validating computerized systems: impact of the new OECD consensus document on pharmaceutical laboratories, Pharmanalyis Europe, Advanstar Communications

October 27/28, 1996, Antwerp, Belgium,
L. Huber, How an instrument vendor helps with accreditation and ISO certification, Presented at Quality [R]evolution in Clinical Laboratories, Congress Makers

Seoul and Zagreb1996,
L. Huber, Establishing a quality system in a laboratory, Presented at Hewlett-Packard Seminars

Slovakia, Oct. 24/26 1996,
L. Huber, Quality assurance and instrumentation,
International AOAC/EURACHEM Workshop on Laboratory Quality Assurance, Accreditation and Reference Materials, Smolenice,

Prague, Seoul, Bombay and Bangkok in 1996,
L. Huber, Establishing GLP and GMP Systems in a Laboratory, Presented at Hewlett-Packard Seminars

Seoul, Bombay, Bangkok, Tokyo and Osaka in 1996,
L. Huber, The Application of the Principles of GLP and GMP to Computerized Systems, Presented at Hewlett-Packard Seminars

Seoul, Bombay, Bangkok, Tokyo and Osaka in 1996,
L. Huber, Easy and trouble free validation and qualification of analytical equipment, Presented at Hewlett-Packard Seminars

Seoul, Bombay, Bangkok, Tokyo and Osaka in 1996,
L. Huber, Method validation and system suitability testing - now and in the future, USP and ICH guidelines, Presented at Hewlett-Packard Seminars

Presentations in 1995 and before



Frankfurt, Germany, November 3, 1994,
L. Huber, International aspects of computer validation in regulated environments, Dechema Meeting

Frankfurt, November 5, 1994,
L. Huber, Computer aided validation and analytical quality assurance, Seminar: Validation of analysis methods (to meet the new EC directive on food control - 93/99/EEC), organized by the German Chemical Society

Rome, December 5/7, 1994,
L. Huber and M. Zanetti, Validating automated analytical instruments to meet regulatory and quality standard requirements, Symposium: Analytical Quality Control and Reference Materials

Frankfurt, February 14, 1995,
L. Huber, Validation of computer controlled analytical equipment to meet regulatory requirements, Meeting of the Verband der Feinmechanischen und Optischen Industrie

Essen, Germany, February 22, 1995,
L. Huber, Quality assurance and validation of analytical equipment, Seminar of Dr. Klinkner on 'Validation in the Analytical Laboratory', Haus der Technik

Manchester, UK, February 23, 1995,
L. Huber, Validation of computer controlled analytical equipment, Seminar of the British Royal Society of Chemistry (RCS): Validation of Analytical Methods for Industry: Is it a problem ?

Cologne, Germany, organized by Prof. Dr. Donike, March 23, 1995,
L. Huber, Good laboratory practice in doping control, IOC Accreditation Symposium

April 24/25, 1995 Düsseldorf, Germany,
L. Huber, Validation of computer controlled analytical systems in the pharmaceutical laboratory, Pharmanalysis organized by Advanstar Communications

Innsbruck, Austria, May 1995,
A. Fell, L. Huber, B. Hancock, Validation in HPLC and CE, Moderators of Panel Discussion Session, HPLC 95

Nov. 28/29, 1996, Mannheim, Germany,
Morkowski, Huber, Kromidas, Validation, Moderator of a workshop at Quality in Analysis

Jan. 24/25, 1996 and Sept 18/19, 1996, Mannheim, in German,
L. Huber, Contributions of Instrument manufacturers for qualification and calibration, Presented at Calibration and qualification of analytical instruments in pharmaceutical quality control, Concept Heidelberg

May 20/22 1996, Oberstorf, Germany,
L. Huber, Development of analytical instruments with respect to customer's needs and quality standards, importance for quality and cost management of a laboratory, Second International Sonthofen Symposium: Analytical Quality and Economic Efficiency in Dairy and Food Laboratories,

June 4, 1996, Interlabor, Belp, Switzerland,
L. Huber, System Validation and System Suitability Testing, Validation '96

Sept 18/19, 1996, Stuttgart, Germany,
L. Huber, Validation of Computerized Systems, Workshop at Chromatography Symposium

Sept 25/26, 1996, Essen, Germany,
L. Huber, Validation of Computerized Systems, Moderation of a workshop at Quality Management in the Laboratory

Sept 24/27, 1996, Gemen, Germany,
L. Huber, Quality Aspects in Instrument Software, Computers in Spectroscopy

Essen, Germany, Nov 21, 1996,
L. Huber, Validating Computerized Analytical Systems, Seminar of Dr. Klinkner on 'Validation in the Analytical Laboratory', Haus der Technik,

Seoul, Bombay, Bangkok, Tokyo, Osaka, Buenos Aires, Sao Paulo, Rio de Janeiro and Littlefalls (US) from 1994 to 1997,
L. Huber, International Regulations and Quality Standards - Impact on Analytical Laboratories, Presented at Hewlett-Packard Seminars

Seoul, Bombay, Bangkok, Tokyo, Osaka, Buenos Aires, Sao Paulo, Rio de Janeiro and Littlefalls (US) from 1994 to 1997,
L. Huber, International Regulations and Quality Standards - Impact on Analytical Laboratories, Presented at Hewlett-Packard Seminars

Seoul, Bangkok, Tokyo, Osaka, and Beijing in 1994 and 1995,
L. Huber, GLP/cGMP, Validation Demands and an Instrument Vendor's Response, Presented at Hewlett-Packard Seminars

Seoul, Bangkok, Tokyo, Osaka, and Beijing in 1994 and 1995,
L. Huber, Method Validation and System Suitability Testing, Presented at Hewlett-Packard Seminars

Zagreb, Budapest and Pratislava, 1995,
L. Huber, Laboratory accreditation, Presented at Hewlett-Packard Seminars

Poster Presentations


USA; Atlanta, March 1997,
L.Huber and Mike Thomas, Validation and Qualifications of computerized systems in analytical laboratories, Poster presented at Pittcon '97

USA, Atlanta, March 1997,
A Five Step Validation Program for Food Laboratories, Poster presented at Pittcon '97

Munic, April 23/26, 1996,
L. Huber, A Five Step Validation Program for Analytical Laboratories, Poster presented at Analytica

Munic, April 23/26, 1996,
L. Huber, Quality Assurance for Analytical Instruments for Food Control Laboratories (in German), Poster presented at Analytica

Europe, London, October 21/22, 1996,
L. Huber, A Five Step Validation Program for Pharmaceutical Laboratories, Poster presented at the Pharm Analysis

Europe, London, October 21/22, 1996,
L. Huber, In-line validation as cost effective tool in pharmaceutical quality control, Poster presented at the Pharm Analysis

New Orleans, VA USA, March 1995,
L. Huber and M. Thomas, Automated method validation, system suitability testing, and quality control in the routine, Pittcon

New Orleans, VA USA, March 1995,
L. Huber and M. Thomas, Validation of computer systems in the pharmaceutical analytical laboratory, Pittcon

New Orleans, VA USA, March 1995,
L. Huber and M. Thomas, Validation of computer systems in the environmental laboratory, Pittcon

April 24/25, 1995, Europe, Duesseldorf, Germany,
L. Huber, Automated method validation, system suitability testing and quality control in the routine, Pharmanalysis organized by Advanstar Communications,

Innsbruck, May 29/June 1, 1995,
L. Huber and H. Godel, Validation of computerized HPLC and Capillary Electrophoresis systems, Poster presented at the HPLC 95

Innsbruck, May 29/June 1, 1995,
L. Huber and H. Godel, Automated method validation, system suitability testing, and quality control in the routine for HPLC and CE, Poster presented at the HPLC 95

s in 2002 and earlier