Leveraging Supplier Activities and Testing Under CSA

Leveraging Supplier Activities and Testing Under CSA

To streamline CSV, the U.S. FDA has recommended a number of improvements to life sciences companies in their Computer Software Assurance (CSA) guidance. A key component is using supplier tests and evidence to expedite CSV.

In this webinar, Kneat’s CSA expert, Darren Geaney, explains how to effectively leverage Supplier Activities so you can take advantage of CSA’s benefits without exposing your company to risk.

Attend to Learn:

• How CSA addresses common CSV pain points
• What CSA says about using supplier or vendor testing
• How you should include evidence in your CSV/CSA activities
• What risk-based validation means for your company

Presented by:

Darren Geaney – Process Engineer, 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).