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Seven 2-Day life seminars with 
Dr. Ludwig Huber

For titles, contents and dates, click here

 

62 New Usersclub Additions

- 19 SOPs
- 21 Examples/Checklists
- 8 Forms/Templates
- 2 Master Plans
- 12 Warning Letters 

last update
April 10,  2017

 

Online Audio Seminars come with 10+ Best Practice guides for easy implementation

 

Quality by Design (QbD) for Development and Validation of Analytical Methods

With focus on the analytical lifecycle
Recorded, available at any time

 

FDA Compliant IT Infrastructure and Network Qualification 

With Strategies and Tool Kit for Compliance and System Uptime

Recorded, available at any time

 

Ensuring Data Integrity for FDA/EU Compliance
Comply with FDA Part 11 and EU/PICS Annex 11 for paper, electronic and hybrid records
Recorded, available at any time

 

Understanding the new Revision of USP <1058> 
With examples and procedures for effective implementation

Recorded, available at any time

 

Understanding the New FDA Guidance for Validation of Analytical Methods

With 10+ best practice guides for easy implementation

Recorded, available at any time

 

Learning from Recent Warning Letters related to Part 11 and Computer Validation

With Clear Recommendations for Corrective and Preventive Actions

May 24, 2017

 

Transfer of Analytical Methods According to New FDA, USP and EU-GMP Guidelines
With SOPs, templates and examples for easy implementation
June 1, 2017

 

Validation and Use of Cloud Computing in FDA Regulated Environments

Comply with GXPs, Part 11, EU Annex 11 and other regulations

June 8, 2017

 

Understanding the New FDA Data Integrity Guidance
With examples and procedures for effective implementation

June 13, 2017

 

Contingency and Disaster Recovery Planning for Computer Systems
To Ensure Business Continuity and Compliance
June 20, 20177

 

Analytical Instrument Qualification According the new Revision of
USP <1058>
 

With SOPs, Templates and Examples for easy Implementation
Recorded, available at any time

 

FDA/EU Compliant Handling of OOX Test Results

Learn how to investigate out-of-trend (OOT) and out-of-expectation (OOE) vs. OOS results

Recorded

 

Understanding Quality by Design for the Pharmaceutical Industry

Introduction to Principles, Regulatory Activities and Industry Practices

Recorded, available at any time

 

Impact of Quality by Design on the Analytical Laboratory

Learn through examples on development and validation of analytical procedures

Recorded, available at any time

 

Managing Electronic Raw Data in Regulated Environments

Definition, generation, evaluation and archiving for FDA, ICH, PIC/S and EU compliance

Recorded, available on demand

 

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

 

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

 

 

 

April 2017

FDA updates the Document  on "FDA Acceptability of Standards from Alternative Compendia (BP/EP/JP)"

This Manual of Policies and Procedures (MAPP) provides clarification to Office of Pharmaceutical Quality (OPQ) reviewers on the appropriate use of quality standards for excipients, drug substances, and drug products found in alternative compendia, specifically the British Pharmacopoeia (BP), the European Pharmacopoeia (EP), and the Japanese Pharmacopoeia (JP), during chemistry, manufacturing, and controls (CMC) review of new drug applications (i.e., investigational new drug applications (INDs) and new drug applications (NDAs)). The document can be downloaded from the FDA website.

 FDA Warning Letter recommends investigating API batches that were tested using non-validated Methods

The warning letter reads: our inspection revealed that you had not validated your method for measuring water content. According to your response, you now have completed method validation for water content. However, your response is inadequate because it does not detail your investigation into the released API batches tested using non-validated method. In response to this letter, provide: a)Retrospective review or retesting of all batches of (b)(4) that remain within retest period or expiry and b) A review of all test methods to ensure they are validated. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 307).

EMA Publishes Implementation Strategy of ICH Q3D Guideline

The purpose of this document is to address specific considerations to enable the practical implementation of ICH Q3D Guideline for Elemental Impurities in the European Union. It is intended to provide guidance for Applicants/Marketing Authorization Holders (MAHs), drug product, drug substance and excipient manufacturers, as well as regulators. In addition to new applications, it will also apply to variations to existing authorized medicinal products The document is available for download from the EMA website.

10 New In-Person Seminars in 2017 with Dr. Ludwig Huber

Labcompliance has extended the offerings for in-Person workshops in several areas: "Data Integrity: FDA/EU Requirements and Implementation", "Validation and Part 11 Compliance of Computer Systems and Data", "GMP Compliance for Quality Control and Contract Laboratories", "Analytical Method Validation, Verification and Transfer", and "Analytical Instrument Qualification and System Validation". All workshops can be delivered as public and as in-house workshops. Currently the workshops are offered in USA, Europe and Asia. For a complete list of workshops with ordering process and links to pages with individual contents, click here.

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Publishers Note

PUBLISHER'S NOTE: Some of the documents presented in this News section may require registration to the Labcompliance Usersclub to access their information. At the time of the News release, all links to other websites functioned, but Labcompliance cannot guarantee the accuracy of the information and that the links will not disabled.