Since the requirement for test method validation appeared in the GMPs in 1978, the industry has considered that test method validation as a onetime event in the life of a test method. This concept was supported by interpretations of USP Validation of Compendial Methods first published in the 1980s and ICH Q2(R1), which was finalized in 2005. However, the pharmaceutical industry, as all industries, is now taking a more proactive view of all processes and has adopted a lifecycle approach to process understanding and validation. As a result of a recent publication of a USP stimulus article there is now a move to apply the lifecycle approach to test methods. This approach will put more emphasis on a clear definition of the intended use of a test method and the uncertainties associated with a test method.
This audio conference by expert speaker Dr. Jerry Lanese is designed to discuss the lifecycle approach to test method validation and also understand how this approach might impact the method validation practice—from the decision of developing a test method through the discontinuation of the use of the method for the testing of a commercial product.
The session will start with a review of the article on USP Stimulus called, ‘Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification’ and also review the FDA Process Validation Guidance 2011 and how these apply to and impact test method validation.
The 3 stages of test method validation; the importance of Analytical Target profile; and an understanding of measurement uncertainty will serve as the key elements of the discussion. The session will conclude with a review of the test method characteristics of accuracy, precision, linearity, range, and specificity, limit of detection and limit of quantitation, as well as the application of these characteristics through the test method lifecycle.
This audio conference will help the personnel in the Test Method Development Laboratory, Quality Control Laboratory and Quality Assurance to understand the evolving practice of test method validation. You will be able to understand that test method validation is not a onetime experiment performed just before method transfer but a proactive approach that includes the three stages of: Test Method Procedure Design (development and understanding), Test Method Procedure Performance Qualification, and Continued Test Method Procedure Performance Verification.
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
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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