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About BBC Training

Blue Bell Consulting, a premier contract research organization (CRO) headquartered in the U.S., launched “Training Courses on U.S. FDA 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 regulations. Topics of these courses range from, GMP, GLP, and GCP compliance, regulatory requirements of DMF, IND, ANDA, NDA, IDE, 510(k), PMA application to pharmacoeconomics and international market analysis.

Also, FDA GMP training course series have been collaboratively developed by several renowned former U.S. FDA senior inspectors and instructed in the U.S., Europe, and Japan. “Medical Device cGMP: QSR Compliance” training course is developed by the U.S. FDA, which is used as internal training material for its reviewers and inspectors.

Since the “BBC Training” was launched, our Open Training courses have been in high demand, receiving enormous interests and high opinions 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, dietary supplement companyies and Contract Research Organizations (CROs).

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. 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.