New FDA or EMA and USP Guidelines for Transfer of Analytical Methods 2017 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
- 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)
New FDA or EMA and USP Guidelines for Transfer of Analytical Methods 2017 is intended for:
- Lab Supervisors and Managers
- Analysts
- Consultants
- QA Managers and Personnel
- Teachers