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2009 Report of BBC Training Program

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In 2009, the training service pattern of Blue Bell Consulting became “in-house training as primary, open training as secondary”. The two modules accounted for approximately 80% and 20% respectively. Pharmaceutical companies and medical device companies that participated in in-house training occupied half and half. The most popular GMP training courses included GMP interpretation and application, GMP auditing, process validation, and computer system validation. Besides companies in the industry, Blue Bell Consulting also provided in-house drug GMP training service for drug regulatory body. In 2009, Blue Bell Consulting conducted three training programs on U.S. drug GMP and inspection for about 120 GMP inspectors from the State Food and Drug Administration (SFDA) in total.

Besides the regular GMP open courses, Blue Bell Consulting, for the first time, invited a seasoned EU GMP expert to instruct a course on EU GMP and preparation for EMEA/FDA inspection, which appropriately met many attendees’ demands of EU GMP training. Morever, Blue Bell Consulting cooperated with training center of the SFDA again to host a course on U.S. GMP of medical device, which helped the attendants better understand U.S. GMP requirements and get ready for compliance with the upcoming medical device GMP regulation in China.

Thanks to the systematic, practical, and authoritative characteristics of GMP courses, Blue Bell Consulting’s GMP training service enjoyed extremely high reputation and we will keep providing high quality GMP training and GMP consulting services for both pharmaceutical and medical device companies as always.