21 CFR Part 11 Compliance for Computer Systems Regulated by FDA - Webinar

  • ID: 4372268
  • Webinar
  • 90 Minutes
  • NetZealous LLC
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"21 CFR Part 11 Compliance for Computer Systems Regulated by FDA" Has Been Pre-Approved by RAPS as Eligible for Up to 12 Credits Towards a Participant's RAC Recertification Upon Full Completion
Overview:

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA's 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed.
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  • Carolyn (McKillop) Troiano Carolyn (McKillop) Troiano,


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  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Analytical Chemists
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing and Supply Chain Managers and Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts in FDARegulated Functional Areas
  • Business System/Application Testers in FDARegulated Functional Areas
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