Risk-Based Approach 2020 - A Critical Step in Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA.
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations.
Learn how to identify “GxP” Systems
Discuss the Computer System Validation (CSV) approach based on FDA requirements
Learn about the System Development Life Cycle (SDLC) approach to validation
Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
Speaker:
Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs