Webinar
Release Date
September 21, 2023
Webinar length
60 minutes
Learn to future-proof your CSV program, reduce risk, boost efficiency, and adapt to changing regulations in this must-see webinar.
With automated test systems you need to have a programmer’s level of skill to script and maintain test datasets. Kneat gives us the ability to author and execute in the traditional manner, without paper.
Speakers
Darren Geaney, BEng, Kneat
Kathianne Ross, Manager of IT Compliance, Fujirebio Diagnostics
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).
Manager of IT Compliance, Fujirebio Diagnostics
Kathianne (Kat) Ross is the Manager of IT Compliance at Fujirebio Diagnostics, Inc., (FDI) and is a Subject Matter Expert in FDA 21 CFR Part 11 and GAMP methodology for development and validation of GxP computerized systems. She has over 25 years of experience planning, executing, and managing all aspects of system development and validation projects for proprietary software, as well as COTS software sold commercially (as the vendor), and purchased (representing the end user).
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