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Transfer of Analytical Methods and Procedures according to USP 1224
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Instructor Profile:
Ludwig Huber, Ph.D., is the director of Lab compliance, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world.
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Description: When validated methods are transferred between
laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published an updated general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. In addition the FDA has included requirements for method transfer in its new draft guidance from 2015 on validation of analytical methods. This webinar will give a good understanding of USP and FDA requirements and provide recommendations and tools for effective implementation.
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Objectives of the Presentation:
• FDA and International expectations for method transfer• Examples of FDA warning letters and how to avoid them• The FDA Guidance on method transfer• The USP chapter <1224>: history, status, future• Four approaches for analytical method transfer and testing• Responsibilities of the transferring and receiving laboratory• Developing a transfer plan and a pre-approval protocol• Conducting comparative studies• Criteria and approaches for risk based testing: What, when, how
much?• The importance and selection of acceptance criteria• Most likely failures during method transfer• Handling deviations from documented acceptance criteria• Method transfer protocol and summary report.
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Areas Covered:
• The new general chapter provides guidance on the basic steps of this process. The chapter describes the most common practices of method transfer which are: Comparative testing
• Co-validation between two laboratories or sites
• Complete or partial method validation or revalidation
• Omission of formal transfer, transfer waiver data and any deviations from the protocol.
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Who can Benefit:
• Consultants• Lab Supervisors and Managers• QA managers and personnel• Analysts• Consultants• Teachers
Track this Link:
USP 1224
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
