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Jan 2015

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
December 1, 2014

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

 

Ten 2-day In-person Interactive GMP, Part11 and Validation seminars available in America, Europe and Asia delivered by Dr. Ludwig Huber. 

 

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

 

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.

 

 

 

Health Canada reminds drug manufacturers about the importance of data Integrity

Health Canada has sent a letter reminding all Drug Establishment License holders of their regulatory responsibilities and obligations when it comes to maintaining good manufacturing practices. Based on recent inspections data integrity was mentioned as specific concern. The letter reads: "Data integrity issues have recently been noted in several facilities domestically and globally. Health Canada continues to monitor these issues and expects regulated parties to provide information as requested while also demonstrating how the integrity of data is ensured in their facilities as well as any facilities with which they are linked through contractual agreements." In the same letter, the agency also announced plans to ramp up announced and unannounced inspections of manufacturing facilities due to increasing data integrity issues. More in formation is available on the Health Canada website.  Attend the new Labcompliance seminar to learn everything about regulatory expectations for data integrity and get 10+ best practice guides for easy implementation.

New FDA Guidance for Demonstrating Biosimilarity to a Reference Product

This industry guidance "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product" is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for purposes of the submission of a marketing application under section 351(k) of the Public Health Service Act. The guidance focuses on therapeutic protein products and gives an overview of important scientific considerations for demonstrating biosimilarity. The scientific principles described in this guidance may also apply to other types of proposed biosimilar biological products The guidance can be downloaded from the FDA website.

300 GxP Warning Letters on the Labcompliance Users Club Website

Labcompliance regularly analyzes FDA warning letters, 483 inspectional observations and establishment inspections reports for current inspection issues. Key findings are reported through the Labcompliance Newsletter. While the Warning Letters are also available from the FDA website they are mainly related to marketing issues. The inspection reports on the Labcompliance website only deal with issues related to GMP, GCP and GLP for drug and medical device industry. The site also includes keywords searchable through the browser and most important excerpts. Userclub members can access the site at any time.Non members still have access to the keywords and excerpts.

New FDA Warning Letters with Data Integrity Issues

FDA inspections and data integrity seems to become a never ending story. This is proven through two FDA warning letters from June going to drug and API manufacturers. Examples for cited violations are: Failure to record activities at the time they are performed, e.g., the batch records do not demonstrate that the required review was completed before before releasing the products. Other examples are destruction of original records, failure to prevent unauthorized access or changes to data, no audit trail and no plan to ensure integrity of raw data. The warning letters can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 300 and 299).  To learn everything about FDA expectations for raw data, attend the Labcompliance audio seminar  Managing Electronic Raw Data in Regulated Environments

NEW FDA Guidance on Risk Evaluation and Mitigation Strategies:
Modifications and Revisions 

The guidance provides information on how the FDA will define and process submissions from application holders for modifications and revisions to approved risk evaluation and mitigation strategies (REMS). Specifically, this guidance provides information on what types of changes to REMS will be considered
modifications of the REMS, as described in section 505-1(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and what types of changes will be
considered revisions of the REMS. The guidance is available for free download from the FDA website.   

Free Document of the Month

As a 'Thank You' for our visitors Labcompliance offers every month one document for free. This month's document is the Best Practice Document "SOP: Handling of Out-of-Specification test Results". To download your free copy, go to the Laboratory Compliance Package website. Scroll down and click on the corresponding ICON on the left (offer expires on September 15, 2015). Labcompliance offers more than 150 SOPs and other documents that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

New Audio Seminars

Class Room Workshop  in Zurich by Dr. Ludwig Huber

New or Updated Sites

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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.