Since the turn of the century, the FDA has been telling the industry that it will regulate using a quality system model; encourage risk-based compliance management; and implement science-based regulation of product quality. Prior to 2008, the agency published several guidance and draft guidance that promote a quality system approach. In 2008, the International Conference on Harmonization released ICH Q10, The Pharmaceutical Quality System, which has become the center point for subsequent guidance and regulations published by ICH, FDA, the European Union and other pharmaceutical industry focused organizations.
The FDA is expecting pharmaceutical firms to have a lifecycle approach to all aspects of commercial production and product and test method development. The concepts identified in ICH Q10 are the foundation for most FDA inspectional activities and consistent with quality system concepts applied through a wide range of industries beyond the FDA regulated industries.
This webinar by expert speaker Dr. Jerry Lanese will discuss how the quality system concepts delineated in ICH Q10 impact the interpretation of the US GMPs and the content of guidance and regulations published in the US and EU. The session will help personnel in Management, Quality Assurance, Pharmaceutical and Test Method Development understand the new guidance and anticipate future emphasis by the regulators.
Who Should Attend
At the Q&A session following the live event, ask a question and get advice unique to your information management situation, directly from our expert speaker.
- Casper E. Uldriks
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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