56 Usersclub Additions
- 15 SOPs
- 10 Examples/Checklists
- 3 Forms/Templates
- 7 FDA Presentations
- 21 Warning Letters
2-day seminar
Computer System Validation and
Part 11
Compliance
by Dr. Ludwig Huber
June 05&06 2013
Istanbul, Turkey

Online Audio Seminars come with 10+ Best Practice guides for easy implementation
FDA/EMA Compliance of Genotoxic Impurities
Understanding and Implementing the new ICH M7 and other Guidelines
May 14, 2013
Comparing GLP with GMP
Learn about similarities and differences and when to apply one or the
other
May 7, 2013
How to Ensure Integrity of Laboratory Data
Comply with new FDA inspection practices and EU Annex 11 requirements
May 23, 20133
Regulatory Aspects of Biosimilar Biological Products
Understand and Implement recent FDA and updated EMA Guidances
June 13, 2013
Transfer of Analytical Procedures According to the New USP Chapter <1224>
With SOPs, templates and examples for easy implementation
Recorded, available at any time
Elemental Impurities According to the Final USP Chapters 232/233
With updates on the new ICH Q3D Guide: Elements, Limits and Schedule
Recorded, available at any time
Quality by Design (QbD) for Analytical Method Development and
Validation
Learn how to design robustness for easy transfer and to avoid
OOS situations
Recorded, available at any time
Efficient Training Practices for FDA and International Compliance
Learn what to train - How much to Train - How to Document
Effectiveness
February 7, 2013
Validation and Use of Cloud Computing in FDA Regulated
Environments
Comply with GXPs, Part 11, EU Annex 11 and other regulations
Recorded, Available at any time
Understanding and Implementing the New EU-PIC/S Annex 11
Prepare Yourself for the upcoming Inspections and Enforcement
Recorded, available at any time
Laboratory Equipment Qualification according to USP <1058>
With SOPs, Templates and Examples for Easy
Implementation
Recorded, available at any time
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
Recorded
Available at any time
FDA/EMA
Requirements for Genotoxic Impurities
Understanding and Implementing the ICH M7 and other Guidelines
May 15, 2013
Qualification and Use of Virtual Networks in Regulated Environments
With Strategies and Tool Kit for Compliance and System Uptime
Recorded, available at any time
Validation and Use of Excel® Spreadsheets in Regulated Environments
Comply with Part 11, QSR, and Annex 11.
Recorded
Available at any time
Implementing
the New USP Chapters 232/233 for Elemental Impurities
Learn how to comply with FDA, USP and ICH Requirements
Recorded, available at any time
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
Recorded, available at any time
How to Prepare Yourself for FDA's on-going Part 11 Inspection
Program
Learn what the FDA is looking for and how to respond
Recorded
Validation of Bioanalytical Methods and Procedures
Conduct and Document for Efficiency and FDA&EMA Compliance
Recorded, available at any time
Raw Data
in FDA Regulated Environments
FDA/EU compliant recording, maintenance and archiving
Recorded, available at any time
Learning
from Recent Warning Letters Related to GMP Laboratory Controls
For Preparation of FDA and International GMP Laboratory Inspections
Recorded, available at any time
Development and Validation of Stability Indicating Methods for
FDA/ICH
Compliance
Sample generation - method development - validation - documentation
Recorded, available at any time
FDA
Compliant Use of (Certified) Reference Material
With 10+ Best Practices for easy Implementation
Recorded, available at any time
Analytical Instrument Qualification According to USP <1058>
With SOPs, Templates and Examples for Easy Implementation
Recorded, available at any time

with 10+ validation examples, seminar with FDA's Dennis Cantellops and
Ludwig Huber and with 13 SOPs for easy implementation.