Many FDA inspections include an in-depth assessment of laboratory operations and investigators have made significant observations of non-conformance to the GMPs in the laboratory during site inspections. Laboratory personnel should be aware areas of non-compliance observed by investigators and proactively implement systems that will prevent similar observations in their laboratory.
Recent FDA investigations have resulted in observations covering inadequate investigations of Out-of-specification results, inadequate testing of incoming materials, data integrity, not following procedures and other non-conformances with GMPs. All laboratory staff should be aware of the parts of the GMPs that apply to the laboratories and areas in the laboratory the agency is most concerned about and proactively implement systems that will help the laboratory avoid FDA observations.
This audio session by expert speaker John G. (Jerry) Lanese will provide the personnel in the quality control laboratory an understanding of their role in maintaining a compliant laboratory operation. It will also provide laboratory managers and auditors of Quality Control laboratories areas to review to assure compliance. Discussions in this session will be based on non-conformances most often cited by the FDA and the pertinent regulation.
Who Should Attend
At the Q&A session following the live event, ask a question and get advice unique to your situation, directly from our expert speaker.
- Dr. Jerry Lanese,
- Edward F. O’Connor, Ph.D.
- Norma Skolnik,
- Dr. Karl Lintner,
- Norma Skolnik,
- Danielle DeLucy, MS
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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