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Version 4 just released

With strategies and tools for fast, cost-effective Laboratory Accreditation

With Quality Manual and  SOPs for easy implementation

 

71 New Usersclub Additions
last update
April 20, 2016

- 20 SOPs
- 23 Examples/Checklists
- 7 Forms/Templates
- 4 Master Plans
- 4 Reference papers
- 13 Warning Letters

 

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

 

Understanding the New FDA Data Integrity Guidance
With examples and procedures for effective implementation
June 2, 2016

 

Integrity of Laboratory Data for FDA/EU compliance

Understand and implement data integrity through the entire data life cycle
June 23, 2016

 

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

With focus on conducting the risk assessment process

Recorded

 

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 with all reference material at any time

 

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

With Clear Recommendations for Corrective and Preventive Actions

Recorded, available at any time

 

Understanding the Final FDA Guidance for Validation of Analytical Methods

With 10+ best practice guides for easy implementation

Recorded, available at any time

 

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

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

 

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

 

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

Learn how to design robust analytical for easy transfer and to avoid OOS situations

Recorded

 

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

 

FDA/EU Compliant IT Infrastructure and Network Qualification

With Strategies and Tool Kit for Compliance and System Uptime

Recorded, available at any time

 

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 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

 

Learning from Recent Warning Letters Related to GMP Laboratory Controls

For Preparation of FDA and International GMP Laboratory Inspections

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.

 

 

 

FDA has published the Draft Guidance:  Data Integrity and Compliance With CGMP

In recent years, FDA has increasingly observed CGMP violations involving data integrity lapses during CGMP inspections. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. The new draft guidance answers 18 questions related to data integrity for cGMP compliance. The guidance also. clarifies the following terms as they relate to CGMP records: data integrity, metadata, audit trail, "static" and "dynamic" record formats, backup, and "systems” in “computer or related systems”.  To learn everything about how to implement the new guidance and to receive 10+ best practices guides, e.g., SOPs and examples, attend the new Labcompliance audio seminar: "Understanding the new FDA Guidance: "Data Integrity and Compliance With CGMP".  The FDA draft guidance can be viewed and downloaded from the FDA website.

"Training Material not available in local Language" and "Data Integrity Lapses" draw an FDA Warning Letter

The warning letter states: "During interviews with our investigators, your contract employee was unable to explain the material he was required to present during training. In addition, while a significant number of your contract employees do not speak English, you only provided English training materials to these employees." 
The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 303).  To learn everything about FDA expectations for training, attend the Labcompliance audio seminar "Efficient Training Practices for FDA and International Compliances".

FDA Releases Draft Guidance for Industry: “Labeling for Biosimilar Products

On March 31, FDA released draft guidance for industry “Labeling for Biosimilar Products.” This guidance provides an overview of FDA’s recommendations for biosimilar product labeling and is intended to assist industry in developing draft labeling for submission in proposed biosimilar product applications. A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. The approval pathway for biosimilar products was established by the Biologics Price Competition and Innovation Act of 2009, which was enacted as part of the Affordable Care Act in March 2010. The draft is available on the FDA website.

"Failure to maintain, repair and clean Buildings" and data integrity issues cited in an FDA Warning Letter

 In a recent inspection of an API manufacturer the FDA found failure to properly maintain, repair, and clean buildings used in the manufacture of APIs. The investigator observed rust, dirt, lubrication leaks, and exposed insulation material on and around open drug manufacturing equipment. Furthermore the FDA found several deviations related to data integrity. For example: the API manufacturer failed to maintain complete data of analytical test records and to investigate past shipments for incomplete test records  derived from all testing. The warning letters can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 301).  To learn everything about FDA expectations for data integrity, attend the Labcompliance audio seminar  "Ensuring Data Integrity for FDA/EU Compliance".

New Ph. Eur. General Chapter on Chemometrics now available

The European Pharmacopoeia has published a new General Chapter on Chemometric methods applied to analytical data (5.21) in Supplement 8.7. The Ph. Eur. is the first pharmacopoeia to have elaborated such a chapter and it should encourage the use of chemometric methods for the evaluation of data currently generated mainly by spectroscopic methods like near-infrared, Raman or mass spectroscopy. The chapter is for information only and is not legally binding. To learn about more details read the press release.

 

 

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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.