Recent FDA Observations and Regulatory Emphasis on Science and Risk and its Current Interpretation of the GMPs
In 2001 the FDA announced to the pharmaceutical industry that it would regulate the industry based on good science risk. Since that time the Agency has partnered with ICH in the release of ICH Q8, Pharmaceutical Development, ICH Q9, Risk Management and ICH Q10, The Pharmaceutical Quality System. FDA has also issued guidance on Process Validation, Quality Metrics and Data Integrity. All of these provide contemporary interpretation for a quality system approach to the enforcement of the existing regulation, the drug GMPs, 21CFR211.
Although the drug GMPs have been in effect for more than thirty five years, the FDA regulates based on the current interpretation of that regulation. This interpretation is communicated to the industry through guidance and demonstrated through inspectional observations.
In this webinar expert speaker Jerry Lanese, there will be discussion on guidance issued by the FDA since the turn of the century and how these bring a contemporary interpretation to the drug GMPs. The discussion will be enforced by recent observations which will be used to clarify the regulatory emphasis on science and risk and its current interpretation of the GMPS.
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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