FDA System-based inspections often include the Quality Control Laboratory and in recent years, investigators have made significant observations of non-conformance to the GMPs in the laboratory during site inspections. Laboratory personnel should be aware of the areas of non-compliance observed by investigators and proactively implement and follow procedures that will prevent similar observations in their laboratory.
This conference by Dr. Jerry Lanese will begin with identification of non-conformances most often cited by the FDA and the pertinent regulation. This will be followed by a discussion of specific observations that relate to the laboratory cited in Warning Letters and FDA 483s. The discussion for each observation will include an analysis of what went wrong, systems, procedures and records the laboratory should have in place that would prevent a similar observation and several questions that a laboratory manager or an auditor might ask to assure that appropriate systems, procedures and records are in place and being followed.
This 90-minute audio session will help laboratory personnel critically evaluate key areas in the laboratory operations for compliance and identify areas for improvement.
Areas covered in this audio conference
Benefits of the session: This audio seminar will provide the personnel in the quality control laboratory an understanding of their role in maintaining a laboratory operation that is compliant with FDA’s current interpretation and enforcement of the cGMPs and how the FDA applies contemporary quality system concepts. Discussion will be based on recent FDA observations during laboratory inspections. It will provide laboratory managers and auditors of Quality Control Laboratories areas to review to assure compliance.
Who should attend
- 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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