Seats are limited. Registration closes as soon as capacity is reached.

KENX VIRTUAL TRAINING · HALF DAY · LIVE ONLINE

AI in GxP: Governance, Validation, and Inspection Readiness

Four focused hours on what regulators now expect from AI-enabled systems, and how to build governance and validation evidence that holds up in an inspection.

DATE: Wednesday, October 28, 2026
TIME: 12:00 – 4:00 PM ET
TUITION: $495 per seat

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Bringing your team? Contact info@kenx.org to ask about our team discount.

Seats are limited to keep the session interactive.

Why this training, and why now

The regulatory ground under AI in regulated environments moved fast. Quality and validation teams are being asked for governance, evidence, and answers they were never asked for before.

JAN 2025

FDA draft guidance sets a risk-based credibility framework for AI supporting regulatory decisions on safety, efficacy, and quality.

JAN 2026

Joint FDA and EMA principles extend that thinking across the full medicines lifecycle, from research to post-market.

APR 2026

FDA issues its first warning letter explicitly citing AI misuse as a GxP compliance violation in pharmaceutical manufacturing.

EU AI ACT

AI in medical devices and critical health infrastructure is classified high risk, adding a binding layer alongside GxP.

The four hours

Built from the sessions that drew the most discussion at the KENX AI in GxP conference series, condensed into a working curriculum.

MODULE ONE

12:00 – 12:50

What Regulators Now Expect

The current landscape in plain terms: FDA guidance, FDA and EMA joint principles, Annex 11 and 22 direction, and the EU AI Act. What enforcement so far tells you about where inspectors will look first.

MODULE TWO

12:55 – 1:45

Governance and Intended Use

Establishing intended use as your governance anchor. Classifying AI systems by risk and context of use, defining ownership and escalation paths across IT, QA, and the business, and building an AI system inventory that survives scrutiny.

MODULE THREE

1:55 – 2:45

Validating AI-Enabled Systems

Writing acceptance criteria for systems that do not behave deterministically. Making intelligent systems testable and defensible, qualifying SaaS and IaaS platforms underneath them, and assessing third-party and supplier risk.

MODULE FOUR

2:50 – 4:00

Ongoing Assurance and Audit

Life after go-live: monitoring and observability, continuous validation, AI-driven audit trail review, and a practical methodology for auditing AI systems. Closes with a live Q&A on the questions your own program is stuck on.

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What you leave with

Every attendee receives a working toolkit, not just slides.

An AI system inventory and risk classification template
An intended use statement template with worked examples
An acceptance criteria checklist for AI-enabled validation
A governance responsibility matrix you can adapt internally
An inspection question set to run against your own program
Access to the session recording for later review

Who should be in the room

Written for practitioners and the leaders who have to sign off on their work. No coding or data science background required.

Validation and CSV/CSA professionals
Quality assurance and compliance leaders
GxP IT and enterprise systems quality
Regulatory affairs and data integrity roles
Manufacturing and laboratory quality
Teams preparing a first GxP AI pilot

Your faculty

Quality, IT and regulatory leaders from regulated manufacturers, teaching the material they presented on stage. No vendor pitches.

Stephen J. Cook

Sr. Director, GRC CSO and Tech Operations, GSK

Leads governance, risk and compliance for global digital and technology operations. Presented on the GSK AI initiative: building and scaling multi-agent AI systems in practice.

Subhabrata Purakayastha

Head of Enterprise GxP IT Systems Quality, Incyte

Presented on defining ownership and accountability for AI across GxP, and on risk-based assurance for AI-enabled systems.

Abhishek Bachchan

Associate Director, IT Security, Risk and Quality, Gilead

Presented on defining acceptance criteria for AI validation: making intelligent systems testable, defensible and inspection-ready.

Raj Muthireddy

Associate Director, Software Quality Assurance & Risk Management, Guardant Health

Presented on interrogating the normal operation of AI systems in GxP: monitoring, observability and operational assurance beyond initial validation.

Registration

INDIVIDUAL SEAT

$495

Live access to all four modules, the full takeaway toolkit, and the session recording afterward.

TEAM RATE

Bringing your team? Contact info@kenx.org to ask about our team discount.

Contact Now

Larger group rates available. KENX does not issue refunds; registrations may be applied to a future KENX event or transferred to a colleague with at least seven days notice.

Common questions

Is this a certification?

No. This is a standalone training course, not a credential. There is no exam and nothing to maintain. You leave with material you can apply to your own program immediately.

Will the session be recorded?

Yes. Registered attendees receive access to the recording afterward, so a scheduling conflict on the day does not cost you the content.

Do I need a technical background?

No. The course is written for quality, validation, and regulatory professionals. The AI concepts are explained from the ground up, in the language of GxP.

How is this different from the AI in GxP conference?

The conference is peer exchange: case studies, practitioner panels, and the room. This is a taught curriculum with a defined syllabus and a toolkit you apply back at your own site.

Wednesday, October 28 · 12:00 – 4:00 PM ET

Four hours that change how your team handles AI in a regulated environment.