Co-hosted with the Training Center of the State Food and Drug Administration, Blue Bell Consulting held a two and half days� training course on Medical Device QSR/GMP in Shanghai on March 23-25, 2009. The course was instructed by Dr. Mel Dong, FDA Compliance & Regulatory Consultant of Blue Bell Consulting.
The course was focused on 換uality System Regulation � Medical Device GMP� and aimed to provide a systematic overview of how to establish and maintain an integrated quality system that meets U.S. FDA抯 QSR/GMP requirements as specified in 21 CFR Part 820for medical device manufacturers. Dr. Dong elaborated on FDA's current interpretations of the QSR/GMP by extensive review of the FDA Regulations, Preambles, Guidelines, Inspection Guides, Quality System Manual, Inspection Observations (483s) and Warning Letters. During Case Study and Discussion sessions, Dr. Dong also gave practical examples of many industry practices for companies with different sizes and products in order to provide attendees with working knowledge of quality system requirements. Many attendants felt that the course was very helpful. They also actively interacted with Dr. Dong and discussed problems they encountered in their daily work.
It is reported that China抯 GMP regulations for medical device may be formally promulgated sometime this year. It seems that medical device industry in China may soon enter into the 揋MP era� following drug industry. In September 2007, SFDA issued administrative provisions for the regulation of medical devices (Draft) and solicited public comments. In the draft regulation, some requirements were quite similar with the U.S. Quality System Regulation. Therefore, learning U.S. QSR/GMP requirements will greatly help the attendants better understand our domestic requirements and get ready for compliance with the upcoming medical device regulation in China. Furthermore, some medical device companies in China have already entered the U.S. market and are expecting FDA inspections. The course provided them a great learning opportunity for their preparations.
From its inception, Blue Bell Consulting has been helping domestic medical device companies to implement their global market strategy. Our services include training, auditing and compliance consulting services on U.S. medical device QSR requirements. We assist medical device firms in the establishment and improvement of their quality system.
