Implementing the New USP Chapter `1224` for Analytical Method Transfer 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 proposal for a new USP chapter `1224`: history, status, future
- The FDA Guidance on method transfer
- Selecting the best approach
- Four approaches for analytical method transfer and testing
- 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?
- Conducting comparative studies
- Dealing with technology transfer: validation requirements, regulatory notification
- The importance and selection of acceptance criteria
- Most likely failures during method transfer
- Method transfer from standard HPLC to UHPLC
- Criteria for transfer waiver (omission of formal transfer)
- Handling deviations from documented acceptance criteria
- Method transfer protocol and summary report
Implementing the New USP Chapter `1224` for Analytical Method Transfer brings together QA managers and personnel, attendees involved in method transfer, Validation specialists, Analysts and lab managers, Documentation department, Training departments and Consultants.
