Blue Bell Consulting:Home > Computer System Validation

Computer System Validation

Who Should Attend?

  • Relevant companies in FDA-regulated industry who need GMP/GLP/GCP compliance
    • Drug & biologics
    • Plant-derived drugs
    • Blood products
    • Vaccines
    • Animal feed and drugs
    • Medical & radiological devices
    • Food & additives
    • Dietary supplements
    • Cosmetics
  • Contract research organization
  • Computer system or software vendors
  • Relevant personnel in the above companies and industries
    • Quality assurance personnel
    • Quality control personne
    • IT specialists
    • Validation specialists
    • Technical support personnel
    • Engineers
    • Management who needs a fundamental understanding of CSV

Course Introduction

This two-day course will introduce the basic FDA compliance requirements of CSV by focusing on the requirement interpretations and using FDA references, industry practices, 483 & warning letter citations. It will additionally provide the attendees with practical skills to develop a computer system validation project by case studies.

Course Outline

  • Basic Review of CSV Compliance Requirements
  • Scope of CSV and Project Preparations
  • Master Validation Plan & Validation Protocol
  • Qualifications & Validations
    • Installation Qualification
    • Operational Qualification
    • Performance Qualification
    • Validation of Security Controls
    • Validation Stress Testing or Worst Case
  • Risk Analysis
    • Key Considerations
    • Tools
    • Documentation
  • Validation Report & Supporting Documentation
  • Change Control & Validation State Maintenance
  • Case Study
  • Q&A /Wrap-up

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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