Implementing the New USP Chapter <1224> for Analytical Method Transfer 2012

• 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.