Quality Digest: The State of Validation in 2026

Ruairi is an experienced engineer with over 10 years of experience in regulated manufacturing. Before joining Kneat, he held Project Engineering roles in the medical device industry with Johnson & Johnson, Stryker, and Cook Medical. He joined Kneat in 2019 as a Project Manager overseeing customer implementations, then moved into Kneat’s Product Management division as Senior Product Manager, where he now leads Kneat Gx’s alignment with industry and regulatory change across Drawing & File Management, AI and Reporting.

Fintan Coady is a CQV and Operational Readiness Specialist with 20+ years in pharmaceutical and biologics manufacturing, combining deep technical expertise with digital transformation to drive efficiency, compliance, and successful facility start-ups

Donncadh has 18 years’ experience across validation disciplines, including process & product validation, equipment and automation qualification, facilities, computer systems, test methods, & cleaning validation. A published author & KENX Editorial Board member, he is also Chair of the BPCI Validation Group.

Durward has over 30 years of hands-on experience with Validation, Qualification, Compliance and Project Management within the Life Science industry. He has experience in a variety of industrial sectors including pharmaceutical, biotechnology, medical devices, food, & healthcare. He has experience in both greenfield and cut and carve brownfield projects in FDA & EMA GMP regulated environments working on behalf of professional services companies.

Marcelo is a senior life sciences validation leader with over a decade of experience in digital and computerized systems validation (CSV). Currently Consultancy & IT Manager at Telstar Brasil, he has led global CSV, SAP implementations, and GxP compliance initiatives, with prior roles at Brainfarma, EMS, AG3 Solutions, and Boehringer Ingelheim.