Medical Device Validation Solutions for Evolving Industry Needs

The use of computer systems in medical device manufacturing has rapidly expanded, creating a growing need for modernized validation approaches. This webinar explores digital computer system validation (CSV) approaches for medical device companies and how teams can build processes to meet the industry’s emerging needs. This session will also outline why traditional validation is shifting, how digital processes address emerging needs and the potential roadblocks to successful transformation.

Digital validation approaches support consistency, reduce redundant effort and help align processes with current regulatory thinking. The featured speakers will discuss the influence of Computer Software Assurance (CSA), how CSA is prompting a reassessment of long-standing validation methods and key considerations for medical device leaders evaluating digital adoption.

This session will provide clarity on how digital validation strengthens compliance and supports scalable, future-ready processes for medical device teams.

Register for this webinar to learn how medical devices benefit from modern digital validation strategies.

Speakers

Kathianne Ross, Manager, 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). Having joined FDI in 2010, she built the company’s SDLC and Change Control programs from the ground up and continues to manage them with a small team responsible for close to 30 different business applications. Since implementing Kneat at FDI in 2020, Kat has facilitated a seamless transition from the previous manual, paper-based system validation process to a fully digital one.

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Tim Akin, Senior Customer Success Manager, Kneat

A Customer Success Manager with Kneat, Tim completed a Bachelor of Science. He established a career in Forensic Science and Chemistry, before applying his strong understanding of quality assurance and validation processes to customer-facing roles within quality assurance software organizations. Tim is a Paperless Validation Subject Matter Expert and works closely with many of Kneat’s largest customers to ensure the success of their digitized validation programs.

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