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About BBC Training

Blue Bell Consulting launched training courses on U.S. FDA GMP regulations in 2005. Emphasized in exporting finished dosage forms to the U.S., these comprehensive and intensive training courses are aimed to fulfill significant unmet needs in China while helping biomedical, pharmaceutical and medical device companies, regulatory bodies, and academic institutions to understand U.S. FDA GMP regulations.

The FDA GMP training course series has been collaboratively developed by several renowned former U.S. FDA senior inspectors and instructed in the U.S., Europe, and Japan.

BBC training courses have been in high demand, receiving enormous interest and high praise from pharmaceutical companies and regulatory authorities. In addition, Blue Bell Consulting has also collaborated with the SFDA Training Center many times to offer GMP training courses and frequently conduct on-site trainings at the invitation of pharmaceutical companies, medical device companies, and regulatory bodies.

Multi-language Training

FDA Drug cGMP Training Course series are instructed in multiple languages worldwide.

Training Types

Courses are open to the public

Course information is publicly announced

Pre-registration for any course is required

Registration fee per person applies

Any company may request special trainings

Topics and materials are specifically catered

Client arranges the training facility

Hourly rate per group attendees applies

Course Instructors

The chief trainer of these training courses is Dr. Mel Dong, FDA Compliance and Regulatory Consultant of Blue Bell Consulting and former U.S. FDAer. Dr. Dong has been providing professional services for 16 years to pharmaceutical and medical device manufacturers all over the world and helping clients to improve overall Good Manufacturing Practice (GMP) compliance level.
As a well-known expert in GMP compliance area, Dr. Dong provides consultation services to the China Food and Drug Administration (CFDA) and provincial CFDA in China on compliance and regulatory issues. Invited as instructor by the CFDA Training Center, Dr. Dong teaches bilingual cGMP training courses for CFDA and provincial CFDA inspectors in China, and of course, for pharmaceutical and medical device companies as well.
Periodically, we will invite internationally renowned experts in the field to join Dr. Mel Dong as co-instructors.

Training Syllabus

Training materials are painstakingly put together by key opinion leaders who have published extensively in the field. Some materials have been used by the U.S. FDA to train its own reviewers and inspectors and by multinational pharmaceutical giants to train their managers, technical staff, and operators. These materials, used in GMP training and FDA application training, are professional, comprehensive, authoritative, and practical with the most current information on U.S. FDA regulations.