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'. In the meantime 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 seminar will give a good understanding of USP, FDA and EU requirements and provide recommendations and tools for effective implementation.
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.
The USP chapter <1224>: history, status, future
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
Examples for conducting comparative studies
Criteria and approaches for risk based testing: what, when, how much?
The importance and selection of acceptance criteria
Method transfer from standard HPLC to UHPLC
Most likely failures during method transfer
Handling deviations from documented acceptance criteria
Criteria for transfer waiver (omission of formal transfer)
Method transfer protocol and summary report
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
Who Will Benefit:
Lab Supervisors and Managers
QA managers and personnel
Ludwig HuberPh.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