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FDA cGMP: Batch Record Review and Investigations


This course concentrates on the practical applications of GMPs and FDA compliance requirements, from the batch record review process to final batch disposition. It begins with practical instructions and techniques for conducting a technical batch record review and identifying batch related discrepancies. The course then shifts to the follow-up investigation of common discrepancies noted from batch production and testing, the decision making process for the final disposition of the batch (i.e., release, reject or rework.)

The course lecture provides the attendees with technical knowledge and understanding of the compliance requirements, and "how-to" instructions for batch record review and follow-up investigations. This is achieved by focusing on the interpretation of the GMPs and FDA requirements, using FDA references, industry practices, FDA-483 citations and "real-life" experiences. The knowledge acquired from the lecture is, then, applied to class workshops to enhance the practical skills for conducting batch record reviews, identifying significant discrepancies, conducting the necessary follow-up investigations, and making the appropriate decision for batch disposition.

All topics and workshops in this course include examples for sterile and non-sterile products.

  • GMP Requirements for Batch Records
  • Recommendations for Reviewing Batch Records
  • Training Batch Record Reviewers
  • Technical Review of Analytical Data
  • Variance/Deviation Systems
  • Class Exercise: Deviation Classification
  • Compliance Requirements for Follow-up Investigations
  • Evaluation of Investigation Findings
  • Review Examples of Investigation
    • Laboratory out-of-specification test results
    • Dissolution test failure
    • Sterility test failure
    • Labeling and product reconciliation discrepancies
    • Labeling and product mix-ups
    • Compliance issues for product reprocessing/rework
  • Preparing the Investigation Report
  • Class Workshop: Batch Record Review
    • Recognition of batch record discrepancies and GMP compliance deficiencies
    • Identifying the potential causes for the follow-up investigation
  • Class Workshop: Conducting an Investigation
    • Investigating LAL failure in water-for-injection system
    • Investigating content uniformity failure

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.