2021 - FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance

Learn how to identify “GxP” Systems
Learn about FDA’s current program for modernization of technology, and how this will impact industry
Learn about FDA’s Technology Modernization Action Plan (TMAP), including what work is underway and what is planned in the near term
Discuss the current state of Computer System Validation (CSV) approach based on FDA requirements
Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation
We will discuss cloud computing and Software as a Service (SaaS) systems that can be embraced and validated effectively
Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures, including ways to improve efficiency and effectiveness
Understand how to maintain a system in a validated state through the system’s entire life cycle in a more cost-effective manner
Learn how to assure the integrity of data that supports GxP work, despite changes and advances in new technology
Discuss the importance of “GxP” documentation that complies with FDA requirements
Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
Know the regulatory influences that lead to FDA’s current thinking at any given time
Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
Q&A