cGMP for Quality Assurance and Quality Control of Pharmaceuticals, Biopharmaceuticals, and Biologics

Venue: The Desmond Hotel & Conference Center

Location: Malvern, Pennsylvania, United States

Event Date/Time: Jan 05, 2009 End Date/Time: Jan 07, 2009
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Participants will gain a thorough foundation in Current Good Manufacturing Practices (cGMP) for both the US and Europe. Day 1 provides a comprehensive introduction to international cGMPs and is also a good refresher for those already experienced in cGMP compliance. Day 2 covers intermediate level topics such as compliance “hot spots,” deviations, out-of-specification results, risk analysis, and auditing for compliance. Day 3 covers advanced topics such as compliance during development, effective compliance strategies, current hot topics, predicting regulatory trends, and shortcuts for staying at the forefront of compliance knowledge. The course concludes with an interactive exercise designed to test your knowledge of cGMP regulations.


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