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Notes from the KENX “Harnessing the Power of AI in GxP” conference (AI in GxP East 2026), held in Raleigh, NC on 2026-09-15 and 2026-09-16. Twenty-three sessions captured live on a Plaud recorder: nineteen lectures and panels, one vendor consultation, and three hallway conversations, all transcribed, summarized, and distilled into evergreen notes.
Maps of Content
- Conference Agenda MOC - every transcript in chronological order, with speakers and session titles
- AI Validation and Acceptance Criteria MOC - continuous validation, acceptance criteria, intended use, LLM judging
- Data Foundations and Audit Trails MOC - governed data estates, agent identity, audit-trail review with local LLMs
- Governance Risk and Human Factors MOC - warning letters, human risk, regulation, security, and the compliance framework talks
- Strategy Scaling and Product MOC - pilot-to-production, MVPs in GxP markets, and the vendor landscape
- Eric’s Field Notes MOC - hallway conversations, the audit war-room debrief, and open threads
Where to start
Three talks anchor the conference’s intellectual spine. Bill Gargano’s keynote argues Validation is data, not an event. Abhishek Bachchan’s lecture argues Validating an AI system in a regulated industry means validating a measurement system. Ben O’Brien’s lecture argues The intended use statement is the master control lever for GxP AI. From there, the theme MOCs above fan out into the rest.
Provenance
- Transcripts are verbatim Plaud captures, lightly corrected for speaker and company names. Diarization and transcription can be wrong; the recordings’ words belong to the speakers.
- Each transcript note carries a summary, the app-generated Plaud AI notes, and (where flagged) Eric’s own highlights, followed by the timestamped transcript.
- Evergreen notes are Eric’s conceptual distillations, titled as claims, each citing the session it was induced from.
- The official agenda compendium PDF lives in Resources.