Current FDA Trends in Inspection and Enforcement Related to Regulated Computer Systems

Pre Recorded

  • 90 minutes

FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment.

This session will address the specific ways to document your computer system validation work to ensure it meets FDA requirements and can pass an inspection. There are specific requirements that must be followed in order for the Agency to consider the documentation valid, and without following these, there is a great risk of FDA invalidating work.

In this webinar expert speaker Carolyn Troiano, will cover the key aspects of complying with 21 CFR Part 11 in both validating systems and maintaining them in a validated state throughout their entire life cycle.

Session Highlights:

  • The most proactive methods for getting ahead of the curve and avoiding computer system validation pitfalls

  • Understand Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology

  • Learn how to document CSV efforts related to “GxP” systems – Good Manufacturing, Laboratory and Clinical Practices (GMPs, GLPs, GCPs)

  • Learn about 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES) Documentation

  • Understand Data Archival to ensure security, integrity and compliance

  • Understand how to effectively document the process of computer system validation, and maintain current information about the systems in your organization and how they are maintained in a validated state

  • Learn about the most current trends in FDA inspection compliance and enforcement related to CSV

  • Learn how to gain information about trends in validation, as industry progresses and new best practices emerge

  • Understand some of the industry best practices to apply when following the CSV process according to the SDLC methodology

  • Learn about system and data governance

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:

  • Information Technology Analysts

  • QC/QA Managers

  • QC/QA Analysts

  • Clinical Data Managers

  • Clinical Data Scientists

  • Analytical Chemists

  • Compliance Managers

  • Laboratory Managers

  • Automation Analysts

  • Manufacturing Managers

  • Manufacturing Supervisors

  • Supply Chain Specialists

*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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