Validating Your Systems and Equipment for Compliance
Date & Time
Thursday, November 17, 2022, 3:45 PM - 4:30 PM

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a sneak peek into what the industry might expect from the FDA’s widely anticipate Computer Software Assurance (CSA) Draft Guidance.

Eric Henry Francisco Vicenty Daniel Walter
Location Name
Gallery 2-3