Navigating 21 CFR Part 11: Ensuring Compliance for FDA-Regulated Electronic Records and Signatures

Carolyn Troiano
Recording Webinar Available @All Days
Recorded Webinar
  

Description

This webinar highlights the importance of ensuring that electronic record and electronic signature (ER/ES) features in FDA-regulated computer systems meet 21 CFR Part 11 compliance. We'll discuss how to develop a company-wide approach to ER/ES compliance and integrate it into your overall computer system validation plan. FDA’s 21 CFR Part 11 was introduced in the late 1990s, but industries like pharmaceuticals have had varied success in implementing it. ER/ES features come with strict requirements, like disabling print capabilities to keep users focused on electronic records instead of paper copies. Additionally, there are rules for identifying users to confirm that the person signing is verified by the system, with secure password protocols.
It’s also crucial that each electronic signature is clear in its intent. For example, the system should specify whether a person is performing, recording, reviewing, or approving work. Responsibilities should be carefully separated, so the person who records results is not the same as the person who reviews or approves them. Specific policies must guide how ER/ES is implemented and used, making it clear how the company meets 21 CFR Part 11 requirements. As FDA regulations evolve, companies must adapt their compliance strategies.

New technologies continue to impact business processes. While they’re often designed to make things easier, some add layers of oversight to validation programs, requiring more resources and making the technology less cost-effective.

Why you should Attend

This webinar provides a detailed understanding of how to apply FDA's 21 CFR Part 11 guidelines for electronic records and signatures in regulated computer systems. This is essential to creating the right validation strategy, ensuring a system works as expected, and keeping it validated from start to finish. The approach should be tailored to each system's specific risk of non-compliance.

Topics Covered:

  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • Good Practice Standards (GMP, GLP, GCP)
  • Validation Strategy
  • System Risk Assessment
  • GAMP 5 "V" Model
  • 21 CFR Part 11 Compliance
  • Electronic Records and Signatures (ER/ES)
  • Security, Access, Change Control, and Audit Trail

Who Will Benefit:

  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Manufacturing and Supply Chain Managers and Analysts
  • Computer System Validation Specialists
  • Business Stakeholders/Subject Matter Experts in FDA-Regulated Functional Areas
  • Business System/Application Testers in FDA-Regulated Functional Areas
  • Any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance

Training Options

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Recording
   $229  

Transcript (Pdf)
   $229  

DVD
   $249  

Recording & DVD
   $389  

Recording & Transcript (Pdf)
   $379  

DVD & Transcript (Pdf)
   $389  

Unlimited Access
   $1499  

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