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2010 Report of BBC Training Program

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GMP training service provided by Blue Bell Consulting in 2010 included in-house GMP training, which accounted for the majority, and a few open GMP training courses. The attendees of our GMP training courses are composed of personnel from two areas, companies that have the need for GMP compliance or upgrade of GMP compliant level and the regulatory bodies that want to enhance GMP inspection skills.

One of the highlights in Blue Bell Consulting’s GMP open training events is a joint course held with PharmaNet, a famous GMP training company in the U.S., in March. We are greatly honored to have invited John Lee, a prestigious GMP expert and the founder of PharmaNet and GMP course series, to come to China to lecture the course, “FDA cGMP Compliance for Dosage Forms: Interpretation and Application”, for the very first time. Dr. Dong provided concurrent translation in highlights for this course. It attracted a great number of attendees from several multinational pharmaceutical corporations or top domestic companies, and governmental personnel from provincial drug regulatory bodies.

Blue Bell Consulting launched a new course titled with “FDA GMP Compliance: Interpretation and Application (Dietary Supplement)”, focusing on the U.S. GMP regulations for dietary supplement that is required for compliance for companies of all kinds of scales. This course concentrated on the FDA's current interpretation of the GMPs with an introduction of acceptable industry practices. The course enabled attendees to obtain a better understanding of U.S. FDA’s GMP requirements and take actions to correct the deficiencies.

Blue Bell Consulting was invited again by Zhejiang Food and Drug Administration (ZJFDA) to conduct drug GMP training. Dr. Mel Dong of Blue Bell Consulting provided an in-house training on GMP inspection of sterile pharmaceuticals for over 80 attendees including several senior supervisors from ZJFDA and its Office of Compliance, and GMP inspectors from Zhejiang provincial, municipal, and district offices.

GMP training of Blue Bell Consulting maintained its high quality characteristics not only in the contents of training materials, but also the performance of instructors. Our GMP training courses have become the first choice for many companies.