Recorded live at MedTech Innovation & Validation University
Use GenAI Responsibly in Validation and Technical Documentation
Developing a proactive strategy to reduce risk. Where generative AI genuinely speeds up validation and technical documentation work, where it introduces exposure you will have to defend, and how to put controls around it before an inspector asks.
Cindy Duhigg
Senior Principal, Global Manufacturing Science & Technology Engineering, Alcon
What you'll take away
- Where generative AI holds up inside a validated process, and where it quietly does not
- The controls and review steps that make AI-assisted documentation defensible
- How to frame the risk conversation with quality before the tool is already in use
- What an inspector is likely to ask when AI touched the record
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Use GenAI Responsibly in Validation and Technical Documentation
Sessions like this one are what MedTech Innovation & Validation University is built on. Keep scrolling for 35+ more, live in Philadelphia on October 7 & 8, 2026.
If you liked this session, there are more like it at
MedTech Innovation & Validation University
October 7 & 8, 2026 · Philadelphia, Pennsylvania · In person or virtual
Co-located with GMP University · $1,795 Early Bird
October 7 and 8, 2026 · Philadelphia, PA
Where the rest of the sessions are.
Two days, thirty-four sessions across the MedTech and GMP agendas, and a faculty of practitioners presenting the programs they run: AI in the QMS, computerized system audits, QMSR, cyber submissions, Annex 1 control strategies, and the inspection questions nobody has clean answers to yet.
Audit insight
How to Survive an Audit of Your Validated Computerized Systems
Practical lessons from real audits of validated systems, what inspectors look for, and how to stay ready.
Raul SotoMedTech Senior Manager, Johnson & Johnson
AI in medical devices
The State of AI in Medical Devices: Lessons learned, hard truths, and the path forward
Tracing AI’s journey in device development — from early algorithm-driven diagnostics to today’s adaptive systems — and the hard lessons on validation, trust, and patient impact that will define the next wave.
Xenophon PapademetrisProfessor of Biomedical Informatics & Data Science, Yale School of Medicine
Annex 1 in practice
Annex 1 in the Real World: Why CCS Documents Look Great on Paper and Fall Apart Under Inspection
Where control strategy documents come apart once inspectors want to see them lived on the floor.
Jim PolarineSenior Technical Service Manager, STERIS Corporation
Change control
Inspection-Proof Change Control: Why Good Changes Still Get 483s
Common change-control failure modes and what 'risk-based' really means to a reviewer.
Cindy Duhigg
“I left with a change-control approach my inspectors accepted.”
MedTech Innovation & Validation University attendee
Speaking from inside the regulated world
Who is on the faculty.
Case studies from the quality, validation, and engineering leaders accountable when a device or a process has to hold up under inspection.
Bristol Myers Squibb
Gilead
Johnson & Johnson
Cencora
STERIS
Alcon
Organon
Getinge
Yale School of Medicine
QualityHub
PQE Group
The Silverman Group
Genari AI
Compliance Group
KNEAT
VTI Life Sciences
See the rest of the sessions in Philadelphia.
October 7 and 8, at the Wyndham Philadelphia Historic District. Co-located with GMP University, so one registration covers both agendas.
$1,795 early bird. Contact KENX for the current deadline.
