Blue Bell Consulting held an open training course on 揊DA cGMP Compliance for Dosage Forms: Interpretation and Application� at Hilton Shanghai on March 8-9, 2010. The attendees included nearly 30 people from several multinational pharmaceutical corporations or top domestic companies, and over 10 governmental staff from Zhejiang FDA and Zhejiang Drug Compliance Center.
Blue Bell Consulting抯 GMP training courses, instructed by our FDA regulatory and compliance consultant, Dr. Mel Dong, use the same training materials as those used in the famous PharmaNet GMP training courses lectured worldwide including U.S., France, Sweden, Italy, and Japan. We are greatly honored to have invited John Lee, a prestigious GMP expert and the founder of PharmaNet and GMP training courses, to come to China to lecture the course for the very first time. Dr. Dong provided concurrent translation in highlights for this two-day course.
During the course, John first introduced the basic rules for interpretations of U.S. FDA抯 GMP regulations. With an in-depth review of the agency's preamble, compliance programs, guidelines, inspection guides, FDA-483, and warning letters, each section of the GMP regulations was reviewed along with the FDA's interpretation of that section. Dr. Dong抯 precise and conclusive translation made it easier for attendees to understand the course contents. At this time, John prepared a precious set of course notes for the attendees, which elaborately summarized FDA抯 interpretations from all different kinds of FDA references for each specific rule in the GMP regulations and could be used as a practical GMP reference book.
Our attendees provided very positive feedback on this lecture and gained a better understanding of our capability and experience in the FDA GMP compliance projects that we are working on with dosage form manufacturers.
