The GMPs require that pharmaceutical firms complete and report an investigation of any product or process deviation or discrepancy. The FDA also reviews these investigations in-depth during most site inspections. As a result, inadequate investigation of deviations or discrepancies is high on the list of FDA observations, and is one of the observations often cited in FDA 483 observations.
Pharmaceutical firms must address discrepancy proactively. However, these firms either do not understand the expectation for, and value of, a thorough, timely investigation, or are not willing to commit the resources to appropriate investigations.
Join this session, where expert speaker John G. Lanese, Ph.D. will discuss the importance of and regulatory expectation for thorough, timely investigations and some of the tools that might be used during the investigation of a deviation.
This session will discuss:
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. David Lim
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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