21 CFR Part 11-FDA’s Guidance for Electronic Records and Electronic Signatures Compliance

Live Webinar

  • 60 minutes

This course is intended to provide specific guidelines for coaching attendees in the concepts of 21 CFR Part 11, namely the FDA requirements for using electronic records and electronic signatures (ER/ES), and the best practices for implementing these technologies in a regulated environment.

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

In this informative webinar our FDA expert speaker Carolyn Troiano, will provide an overview of current industry trends which are related to ER/ES.

Session Highlights:

  • Computer System Validation (CSV)

  • System Development Life Cycle (SDLC) Methodology

  • Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))

  • Validation Strategy

  • System Risk Assessment

  • GAMP 5 “V” Model

  • 21 CFR Part 11 (FDA Guidance)

  • Electronic Records/Electronic Signatures (ER/ES)

  • Electronic System Workflow and Approval

  • Security, Access, Change Control and Audit Trail

  • Policies and Procedures

  • Training and Organizational Change Management

  • Industry Best Practices and Common Pitfalls

Why You Should Attend:

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.

Who Should Attend:

  • Data “Owners”

  • Data “Stewards”

  • Information Technology Analysts

  • Information Technology Developers and Testers

  • QC/QA Managers and Analysts

  • Clinical Data Managers and Scientists

  • Analytical Chemists

  • Compliance and Audit Managers

  • Computer System Validation Specialists

  • Business Stakeholders/Subject Matter Experts

  • GMP Training Specialists

  • Business System/Application Testers

*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Carolyn  Troiano

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, computer system validation and large-scale IT system implementation projects. Carolyn participated in the Industry/FDA partnership that developed 21 CFR Part 11, the FDA’s guidance on electronic records and electronic signatures (ER/ES).

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