Mel Dong, MD, PhD, MBA

Dr. Dong, a veteran of the U.S. Food and Drug Administration (FDA), served in a multidisciplinary team responsible for premarket clearance of submissions by regulated industries and participated in numerous on-site compliance inspections as a member of FDA inspection team.

After his tenure at the U.S. FDA, Dr. Dong provides consulting, auditing, and training services since 2003 to pharmaceutical companies in Greater China, Asia Pacific Area, and around the world in establishing and strengthening his client companies’ Good Manufacturing Practice (GMP) quality systems, developing compliance strategies, and ensuring regulatory inspection readiness. Dr. Dong frequently audits pharmaceutical companies, suppliers, and contract manufacturers in the region and worldwide. He helps his pharmaceutical and biologics manufacture clients in handling of FDA/CFDA inspections, citations, and regulatory actions by developing, implementing, and communicating comprehensive corrective and preventive action plans. He also advises investment firms that are committed to bring innovative products to the market in evaluating the status of regulatory compliance of their target and existing portfolio companies during the performance of due diligence activities.

As a well-known expert in GMP compliance, Dr. Dong has been invited as instructor by the CFDA Training Center to teach bilingual cGMP training courses for CFDA and provincial CFDA inspectors in China. Many CFDA inspectors selected for its increasingly frequent overseas GMP inspections were trained by Dr. Dong in three separate week-long intensive GMP training courses in September and November of 2009.

His portfolio client companies include pharmaceutical companies worldwide with API, solid dosage form, sterile injectable, and aseptic chemical and biological products that are required to comply with the U.S. and China GMPs.

Professional services provided by Dr. Dong mainly include:

  • GMP compliance consultation and gap analyses
  • Mock FDA/CFDA GMP inspections and GMP audits
  • Practical FDA/CFDA GMP training courses, workshops, and seminars
  • Qualification of vendors/contractors, facilities, and equipment/instrument
  • Validation of manufacturing processes, analytical methods, and computer systems
  • Responses to FDA 483s and warning letters
  • Responses to CFDA deficiency letters
  • Coordination of industry meetings with FDA/CFDA

Major training courses instructed by Dr. Dong in either English or Chinese include:

  • cGMP: Interpretation and Application for Dosage Forms
  • cGMP: Interpretation and Application for APIs
  • cGMP: Validation and Qualification
  • cGMP: Laboratory Controls
  • cGMP: Batch Records Review and Investigations
  • cGMP: GMP Compliance Auditing
  • cGMP: GMP Compliance Auditing for Sterile Pharmaceuticals
  • Computer System Validation and Part 11
  • CFDA GMP: Interpretation and Application for API and Dosage Forms
  • Comparison between FDA and CFDA GMPs
  • Preparing, Participating, and Handling a CFDA Inspection