Transfer of Analytical Procedures According to the New USP Chapter [1224] 2016

Topics

• 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)

Who should Attend

• QA managers and personnel
• Lab Supervisors and Managers
• GLP study directors
• GLP auditors
• Consultants
• Analysts
• Pharmaceutical Research
• Teachers
• Contract laboratories
• Pharmaceutical development
• CROs