Name
Validating Your Systems and Equipment for Compliance
Date & Time
Thursday, November 17, 2022, 3:45 PM - 4:30 PM
Description
The three sentences in the Quality System Regulation mandating that software automating manufacturing production or the quality system be validated cover a wide variety of systems from the manufacturing floor to the c-suite. This session will provide an overview of the requirements and available guidance, including a sneak peek into what the industry might expect from the FDA’s widely anticipate Computer Software Assurance (CSA) Draft Guidance.
Speakers
Eric Henry - FDA & Life Sciences Practice, King & Spalding
Francisco Vicenty - CDRH, FDA
Daniel Walter - US FDA
Francisco Vicenty - CDRH, FDA
Daniel Walter - US FDA
Track
Plenary
Location Name
Gallery 2-3