Computer Systems 2020 - Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software - New Course

The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry.
We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) by using automated testing tools that will result in a continuous validation of software products.
Learn how to identify “GxP” Systems
Learn about FDA’s current thinking about technology and software development, and how this will impact industry
Speaker:
Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, tobacco and other FDA-regulated industries.