Transfer of Analytical Methods and Procedures: FDA Requirements and Strategies and Tools for Implementation 2016 is a webinar that covers topics such as:
- Examples of FDA warning letters and how to avoid them
- FDA and International expectations for method transfer
- The USP chapter [1224]: history, status, future
- The FDA Guidance on method transfer
- Four approaches for analytical method transfer and testing
- The new EU GMP chapter 6 on method transfer
- Developing a transfer plan and a pre-approval protocol
- Responsibilities of the transferring and receiving laboratory
- Criteria and approaches for risk based testing: what, when, how much?
- Examples for conducting comparative studies
- Method transfer from standard HPLC to UHPLC
- The importance and selection of acceptance criteria
- Handling deviations from documented acceptance criteria
- Most likely failures during method transfer
- Method transfer protocol and summary report
- Criteria for transfer waiver (omission of formal transfer)
Transfer of Analytical Methods and Procedures: FDA Requirements and Strategies and Tools for Implementation 2016 is intended for attendees from:
- Lab Supervisors and Managers
- Analysts
- Analysts
- QA managers and personnel
- Teachers
- Consultants
