Transfer of Analytical Methods and Procedures: FDA Requirements and Strategies and Tools for Implementation 2016
15 Dec 2016
Webinar
Key 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
Past Events
Transfer of Analytical Methods and Procedures: FDA Requirements and Strategies and Tools for Implementation 2016 - 15 Dec 2016, Webinar (63692)
Transfer of Analytical Methods and Procedures: FDA Requirements and Strategies and Tools for Implementation 2026
Important
Please, check "Transfer of Analytical Methods and Procedures: FDA Requirements and Strategies and Tools for Implementation" official website for possible changes, before making any traveling arrangements
