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56 New 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 15, 2013

 

Setting up a Quality System for Pharmaceutical Laboratories

Understanding and Implementing ICH Q10 and other Quality Systems

March 7, 2013

 

Transfer of Analytical Procedures According to the New USP Chapter <1224>

With SOPs, templates and examples for easy implementation

March 21, 2013

 

Elemental Impurities According to the Final USP Chapters 232/233

With updates on the new ICH Q3D Guide: Elements, Limits and Schedule

April 25, 2013

 

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.

 

 

 

 

Labcompliance News March 2013

FDA Answers Questions related to User Fees for Generic Drugs

From 2013 on generic drug and API manufactures must pay an annual users fee (see Labcompliance News from January). Now FDA has disclosed the fee amounts on its website. A domestic FDF (fixed dose formula) facility has to pay: $175,389, foreign FDF facility: $190,389, domestic API facility: $26,458 and foreign API facility: $41,458. On the same website FDA also answers questions such as: "When will facility fees be due?", "Who is required to pay facility fees?", "Do two locations of the same company have to pay separate facility fees?", and "What is the penalty for failure to pay a facility fee?" 

New FDA Guidance on Formal Dispute Resolution

In the course of drug review, CDER and CBER make a wide variety of scientific and procedural decisions that are critical to a sponsor’s drug development program. Sometimes, a sponsor may disagree with one of these decisions, and a dispute arises. This guidance is intended to provide recommendations for industry on the procedures for resolving scientific and procedural disputes that cannot be resolved at the division level. This guidance describes procedures for formally appealing such disputes to the office or center level and providing information to assist FDA officials in resolving the issue(s) presented.. The guidance can be viewed and downloaded from the FDA website.

"No Acceptance Testing during Method Transfer" cited in FDA 483

FDA expects firms to perform acceptance testing of analytical methods in the receiving laboratory when validated method are transferred between laboratories. The transfer and acceptance testing should follow formal transfer procedures. This became obvious during an inspection of a pharmaceutical manufacturer which resulted in a 12-page 483 inspectional observation from Jan 2013. One of the observation reads: "The firm failed to determine the acceptability of ten methods prior to using them in the QC laboratory through formal method transfer procedures".  The 483 listed other observations, for example: inadequate method, validation, incomplete annual report, quality of incoming raw material not assured, inadequate training, process to endure data integrity not validated, data audit trails  not maintained and instrument audit logs are not saved". The 483 can be downloaded from the Labcompliance Usersclub. Scroll down to W-282. Non members can preview excerpts. To learn everything about FDA compliant transfer of analytical methods attend the seminar: Transfer of Analytical Procedures According to the New USP Chapter <1224>. The seminar includes examples adequate acceptance criteria.

New Global Guidelines and Regulations Impacting Validation Professionals

Dr. Ludwig Huber gave a presentation on this topic at the recent IVT Validation Week in Singapore. .After an update on the new ASEAN GMP harmonization and GMP certification Dr. Huber went through new regulations and guidelines from USP, Europe, PIC/S GAMP with special focus on surprises that came to the industry. The speaker specifically pointed .out new requirements brought by the EU-PIC/S Annex 11 on  Managing Computer Systems and the new EMA draft guidance on process validation. The presentation was finished with a couple of examples for most recent FDA warning letters. Usersclub members can download the presentation, non-members can view contents of the Usersclub sites.

New Publication on Recent Developments of Biosimilar Products

The article "Biosimilar Development: The Race to Market Continues" written by Fiona M Greer of SGS gives a quite detailed update on development and market opportunities of biosimilar products. This article introduces the concept of biosimilars, their importance in the global marketplace together with some historical background, and an update on the current regulatory situation in US and Europe.. It also addresses the issues involved in demonstrating physicochemical similarity of the biosimilar molecule to the originator – one of the first hurdles to be negotiated prior to biological and clinical testing.. As of March 2013 the article is available on the SGS Website. Copyright rests with the publisher. 

FDA 483 Observation caused by  wrong SOP for Method Transfer

An inspection of a drug manufacturer ended with several observations were related to inadequate transfer of analytical methods. In one instance the SOP did not require the receiving laboratory to demonstrate suitability for intended use No specific reason was given. Another SOP was found to be inadequate because it listed several reasons why formal transfer is not required, for example, the analysis technique was already in use at the receiving: laboratory.
While the USP draft chapter <1224> describes waivers as one possible option for method transfer, obviously the justifications given by the company have not been accepted by the inspection team. The 483 can be downloaded from the Labcompliance Usersclub. Scroll down to W-261. Non members can preview excerpts. To learn everything about FDA's expectation for validation and transfer of analytical methods, attend the Labcompliance audio seminar and receive 10+ best practices guide for easy implementation.

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: Quality Assessment of Software and Computer System Suppliers". To download your free copy, go to the Part 11 Compliance Package. Scroll down and click on the corresponding ICON on the left (offer expires on March 31 2013). Labcompliance offers more than 130 SOPs and other documents that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

2-day Seminar with Dr. Ludwig Huber

Validation and Part 11/Annex 11 Compliance of Computer Systems
June 05/06, 2013
Elite World Hotels, Turkey

Audio Seminar Schedule

  1. Transfer of Analytical Procedures According to the New USP Chapter <1224>
    With SOPs, templates and examples for easy implementation
    March 21, 2013
  2. Elemental Impurities According to the Final USP Chapters 232/233
    With updates on the new ICH Q3D Guide: Elements, Limits and Schedule
    April 25, 2013
  3. FDA/EMA Compliance for Genotoxic Impurities
    Understanding and Implementing the new ICH M7 and other Guidelines
    May 15, 2013

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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.