- FDA and International expectations for method transfer.
- Examples of FDA warning letters and how to avoid them.
- The FDA Guidance on method transfer.
- The new USP chapter <1224>: history, status, future.
- Four approaches for analytical method transfer and testing.
- Responsibilities of the transferring and receiving laboratory.
- Developing a transfer plan and a pre-approval protocol.
- Conducting comparative studies.
- Criteria and approaches for risk based testing: what, when, how much?
- The importance and selection of acceptance criteria.
- Dealing with technology transfer: validation requirements, regulatory notification.
- 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.
This webinar will explain the final version of USP Chapter <1224> and FDA guidance for conducting and documenting method transfer between laboratories and sites, and provide tools for effective implementation.
- Lab Supervisors and Managers
- QA managers and personnel
- GLP auditors
- GLP study directors
- Pharmaceutical Research
- Pharmaceutical development
- Contract laboratories
Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. Dr. Huber is the author of the books “Validation and Qualification in Analytical Laboratories” and “Validation of Computerized Analytical and Networked Systems”. He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies.
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