Understanding and Implementing FDA'S 21 CFR Part 11

Instructor: Dr. Ludwig Huber
Product ID: 701867
  • Duration: 75 Min

recorded version

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Understand 21 CFR Part 11 requirements and get a guidance how implement it in a cost effective way. Briefing about part 11 inspections.

Why Should You Attend:

In 1997 the US FDA issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even the rule is more than 10 years old there still many questions related to the scope and real requirements of Part 11.

Attend this 21 cfr part 11 webinar to get a good understanding of current and future FDA requirements and provide steps, examples and tools for cost-effective implementation.

Areas Covered in the Seminar:

  • Overview on Part 11 history and requirements
  • Current and future FDA inspections with focus on computers and electronic records
  • Part 11 requirements that are NOT enforced any more
  • Going through individual requirements:
    • Validation
    • limited authorized access to system and data
    • archiving and retrieval of e-records
    • executing electronic signatures
    • binding signatures with records, training
  • Recommendations for implementation and documentation
  • Bringing existing systems into compliance with minimal effort
  • Responsibilities of vendors and users
  • Going through most common pitfalls
  • Going through frequently asked questions and answers
  • Preparing for Part 11 Inspections

Free Hand-outs : For easy implementation, attendees will receive

  • Part 11 Compliance Master Plan - Ideal to develop or update your company's Part 11 program
  • Part 11: Step-by-step implementation
  • SOPs:
    • Define and Document Scope and Controls for Part 11
    • Electronic Audit Trail: Specifications, Implementation, Validation
  • Gap analysis/checklist: 21 CFR Part 11t

Who Will Benefit:

  • (Bio)Pharmaceutical Companies
  • Device manufacturers
  • Manufacturers of pharmaceutical starting material
  • Clinical Laboratories
  • Software developers
  • IT managers and system administrators
  • QA managers and personnel
  • Users of computer systems in FDA regulated environments
  • Validation professionals
  • Training department
  • Documentation department
  • Consultants

    Instructor Profile:

    Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance for Agilent Technologies. He is the editor of , the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. For more information, visit Dr. Huber's website: .

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