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FDA cGMP: Qualification and Validation


This course reviews the GMP compliance requirements for validation and qualification, and the latest FDA interpretations of these GMP requirements and issues. The practical application of these current GMP compliance requirements, such as revalidation and requalification, qualification of existing equipment, and provisions for validation/qualification matrixing and bracketing, are also discussed. Topics for review and discussion include process validation, installation and operation qualification, validation documentation, and cleaning validation.

Class exercises on validation, qualification and documentation are included to enhance the practical focus and application of this course.

The objectives of this course are to provide the attendees with an updated review of the latest GMP requirements and FDA interpretations for validation and qualification, and practical recommendations for the most effective and efficient methods to achieve a satisfactory level of compliance.

This course is suitable for professionals with a basic or advanced knowledge of GMP/FDA requirements and compliance issues for validation and qualification. The information and exercises in this course will benefit Quality professionals responsible for validation compliance and auditing; and Validation, Engineering and Production professionals responsible for the execution of the validation/qualification, and the preparation of related records.

  • GMP Review and Interpretations for Validation and Qualification
    • Current GMP and FDA requirements
    • FDA accepted validation approaches
    • Conditions and limitations for retrospective and concurrent validations
    • Objective and preparation of master validation plans and related records
    • Worst-case, and bracketing and matrixing
    • Current compliance issues
  • Preparing the Validation/Qualification Protocols
  • Compliance Requirements for Installation Qualification
  • Compliance Requirements for Operation Qualification
  • Compliance Requirements for Process Validation
  • Compliance Requirements for Cleaning Validation
  • Preparing the Validation/Qualification Report

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.