Goodbye Computer System Validation, Hello Computer Software Assurance!
Daniel Walter, CSA & Advanced Manufacturing, CDRH OPEQ FDA
3:15 PM - 4:00 PMTue
Manufacturing
Speakers
Daniel Walter
CSA & Advanced Manufacturing
CDRH OPEQ FDA
This session explores the impact of FDA guidance on advanced manufacturing, including the industry's CSV challenges and the long anticipated Draft Guidance on Computer Software Assurance for Production and Quality System Software released in September 2022.