Computer Systems 2020 - FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries.
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)
Learn how to identify “GxP” Systems
Learn about FDA’s current program for modernization of technology, 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.