Risk-Based Approach 2020 - Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance Webinar

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.
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
Speaker:
My experience includes 34+ years in IT/ Business, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries.