New FDA or EMA and USP Guidelines for Transfer of Analytical Methods 2017

Topics

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

Who should Attend

• Lab Supervisors and Managers
• Analysts
• Consultants
• QA Managers and Personnel
• Teachers