ACRP 2018 Meeting & Expo

337 - Strategies for Ensuring Part 11 Compliance at Research Sites

Apr 30, 2018 1:45pm ‐ Apr 30, 2018 2:45pm


Credits: None available.

Members: $25.00
Standard: $75.00

Description

With the proliferation of electronic regulatory document management systems in clinical research, investigative sites are at risk of compliance findings if they do not have strategies in place to ensure sites comply with 21 CFR 11 regulations. Learn the various aspects and best practice for helping sites build an appropriate risk based approach to Part 11 compliance for their electronic records. Speakers will explore tools to help sites understand their commitments and document their compliance with the appropriate regulation.

Learning Objectives:

  • Understand FDA expectations for investigative sites under Part 11
  • Review implications of draft guidance identify best practices for building a risk-based approach to Part 11 compliance
  • Active programs and systems to maintain Part 11 inspection readiness

Speaker(s):

Credits Available


Strategies for Ensuring Part 11 Compliance at Research Sites

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