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FDA cGMP: Compliance Auditing


Although quality and compliance auditing is not specifically required by drug GMPs, it has been an integral element of many pharmaceutical operations. The FDA has always been in favor of self-audit programs and has issued citations to companies for failing to conduct audits. This course will discuss some of the practical and proven techniques for conducting effective audits of various pharmaceutical operations.

  • Audit Techniques
  • General Compliance Auditing
    • Raw material control
    • Weighing and dispensing
    • Manufacturing controls
    • Packaging and labeling controls
    • Calibration and maintenance programs
    • Quality Assurance programs
  • Auditing API Operations
  • Auditing Validation and Qualification Studies
  • Auditing Purified and WFI Water Systems


Course Instructor

Mel Dong, MBA, PhD, MD
Dr. Dong was a U.S. FDAer responsible for premarket clearance of submissions by regulated industries as well as a member of FDA inspection team and participated in numerous on-site inspections. With over 20 years of experience in the U.S., Dr. Dong founded Blue Bell Consulting in Shanghai, China in 2003, dedicating his world-class services to pharmaceutical manufacturers in Greater China, Asia Pacific Area, and around the world helping clients improve overall Good Manufacturing Practice (GMP) compliance level. Selected by domestic and international pharmaceutical companies, Dr. Dong frequently audits pharmaceutical suppliers and contract manufacturers in the region. He also helps API and dosage form pharmaceutical companies in China in handling of FDA inspections, citations, and regulatory actions. Representing clients, he coordinates and participates industry meetings at the FDA headquarter in U.S.
As a well known expert in GMP compliance area, Dr. Dong also frequently provides consultation to the State Food and Drug Administration (CFDA) and provincial FDA agencies in China with expert views on compliance and regulatory issues. Invited as instructor by the CFDA Training Center, Dr. Dong has been offering bilingual cGMP training courses for CFDA and provincial CFDA inspectors in China, of course, for also managers of pharmaceutical companies around the world. Invited by regulatory bodies of Beijing, Zhejiang, and Shanghai, Dr. Dong has often been invited as a keynote speaker in seminars on compliance and regulatory issues.


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