21 CFR Part 11 Compliance: Facts & Myths


Myths vs Facts

  • Understanding misinterpretations related to Part 11
  • What is really applicable to the industry?
  • Breakdown of Myths vs Facts related to Part 11
  • What is enforcement discretion and what is means to the industry?

What is out of the scope of enforcement?

  • Learn where Part 11 is no longer applicable
  • What does out of scope mean to the industry?

Which records are in the scope of enforcement?

  • Learn to understand records that must comply with Part 11
  • How to identify records that need to comply with Part 11

Assessments tools for Part 11 Compliance?

  • Learn how to create tools to assessment Part 11 applicability
  • Overview of tools to simplify Part 11 requirements definition

Recent FDA Observations?

  • Overview of recent Part 11 FDA observations
  • Inspections trends and what they mean to the industry

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Comments (2)

Hi Damodharen, thank you for the feedback. We have a selection of videos available on the site but we are always looking to improve our selection. If you have an idea in mind for a GMP training video, please email [email protected]. - IVT Network Team

Can you provide some GMP training videos.

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