• What the FDA’s September 2022 CSA guidance means for validating computer systems
• How CSA reduces documentation burden and issues in production through unscripted and ad–hoc testing
• How to shift from CSV to CSA through risk–based critical thinking
• Why a digital validation solution is the best way to realize CSA’s benefits

Presented by:

Darren Geaney, BEng, Kneat
A Computer Systems Validation specialist, Darren has over 23 years’ experience in software validation, providing right-sized computer system validation solutions to medical device companies. Knowledgeable in regulations FDA 21 CFR Part 820, 21 CFR Part 11, ISO 62304 and ISO 14971, Darren is ‘Lead Auditor’ accredited and experienced in supporting both internal and external audits (including FDA, IMB, TUV, and BSI).