New FDA or EMA and USP Guidelines for Transfer of Analytical Methods


Duration: 75 Minutes  

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Dr. Ludwig Huber   Product Id : 501277
  Instructor : Dr. Ludwig Huber

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Overview:

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published an updated general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. In addition the FDA has included requirements for method transfer in its new guidance from 2015 on validation of analytical methods. And last but not least Europe has released an updated GMP Chapter 6 with clear requirements for comparative testing and acceptance criteria. This Webinar will give a good understanding of USP, FDA and EU requirements and provide recommendations and tools for effective implementation.

For easy implementation, attendees will receive:

  • SOP: Transfer of Analytical Methods
  • Checklist: Transfer of Analytical Methods and Procedures
  • Master Plan template and examples: - Transfer of Analytical Methods and procedures

Areas Covered in the Session:
  • FDA and International expectations for method transfer
  • Examples of FDA warning letters and how to avoid them
  • The FDA Guidance on method transfer: examples for type and extent of testing
  • Comparative testing according to the new FDA method validation guidance
  • The USP chapter <1224>: history, status, future
  • Gap analysis according to the new EU GMP chapter 6 on method transfer
  • Four approaches for analytical method transfer and testing
  • Responsibilities of the transferring and receiving laboratory
  • Developing a transfer plan and a pre-approval protocol
  • Criteria and approaches for risk based testing: what, when, how much?
  • Selecting parameters and acceptance criteria for comparative testing
  • Method transfer from standard HPLC to UHPLC
  • Most likely failures during method transfer
  • Handling deviations from documented acceptance criteria
  • Justification and criteria for transfer waiver (omission of formal transfer)
  • Method transfer protocol and summary report

Who Will Benefit:
  • Analysts
  • Lab Supervisors and Managers
  • QA Managers and Personnel
  • Consultants
  • Teachers


Speaker Profile
Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber’s website www.ludwig-huber.com




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