Transfer of Analytical Procedures According to the New USP Chapter [1224] 2016 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 new USP chapter [1224]: history, status, future
- The FDA Guidance on method transfer
- Responsibilities of the transferring and receiving laboratory
- Four approaches for analytical method transfer and testing
- Conducting comparative studies
- Developing a transfer plan and a pre-approval protocol
- The importance and selection of acceptance criteria
- Criteria and approaches for risk based testing: what, when, how much?
- Method transfer from standard HPLC to UHPLC
- Dealing with technology transfer: validation requirements, regulatory notification
- 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)
Transfer of Analytical Procedures According to the New USP Chapter [1224] 2016 is intended for:
- QA managers and personnel
- Lab Supervisors and Managers
- GLP study directors
- GLP auditors
- Consultants
- Analysts
- Pharmaceutical Research
- Teachers
- Contract laboratories
- Pharmaceutical development
- CROs
