Transfer of Analytical Methods and Procedures: FDA Requirements and Strategies and Tools for Implementation 2016

Topics

• 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)

Who should Attend

Attendees from:

• Lab Supervisors and Managers
• Analysts
• Analysts
• QA managers and personnel
• Teachers
• Consultants