One of the questions asked when an organization validates a test method is: What acceptance criteria should we use? Often, acceptance criteria have been based on internal, organizational conventions with little consideration on the intended use. With the publication of the USP Stimulus Article, *Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification along with the FDA 2011 Process Validation Guidance, it is clear that the determination of acceptance criteria must focus on the intended use of the method and include considerations of the test method uncertainty.
In this session by expert speaker Dr. Jerry Lanese he will discuss the lifecycle approach to test method validation and how it will impact acceptance criteria. This session will discuss the practice of method validation from the decision to develop a test method through to the discontinuation of the use of the method for the testing of a commercial product.
The session will begin with a review of the USP Stimulus Article*mentioned above along with the FDA 2011 Process Validation Guidance and discuss how these apply to and impact test method validation. Key elements of the discussion will be the three stages of test method validation and the importance of the Analytical Target Profile and an understanding of measurement uncertainty. The discussion will conclude with a review of the test method characteristics and how the determination of intended use will impact each.
This session will help the personnel in the Test Method Development Laboratory, Quality Control Laboratory and Quality Assurance understand the evolving practice of test method validation. The presentation is based on the premise that test method validation as one experiment that is performed just before method transfer must be replaced with a proactive, lifecycle approach that includes the three stages of test method validation. Further, it establishes the importance of how organizations and analysts should understand the concepts of Analytical Target Profile and have knowledge of the uncertainties of the test method, and therefore the reported results.
Who should attend?
Dr. John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where...
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