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.
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Review implications of draft guidance identify best practices for building a risk-based approach to Part 11 compliance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