- Save the Date · May 11-12, 2027
- Conference
AI in GxP: Pilot to Production to Scale
Real Deployments. Real Validation. Real Scale.
- May 11-12, 2027
- San Francisco, CA
Special Rate ends December 31
Need approval? Download a justification letter
Overview
From Proof of Concept to Proof of Value.
Most life sciences companies have run AI pilots. Far fewer have moved them into validated, production GxP use. The gap is rarely the technology. It’s validation strategy, data readiness, change management, and the confidence to stand behind an AI system during an inspection.
Built for the gap
AI in GxP: Pilot to Production to Scale is built for that gap. This isn’t a conference about what AI might do someday. Every session centers on real implementations: what was deployed, how it was validated, what broke, and what it took to scale from one site or one use case to many.
From the people doing it
You’ll hear directly from manufacturers who have taken AI into validated production across quality, manufacturing and the laboratory, and you’ll leave with frameworks you can apply the following week.
Outcomes
What the Program Covers.
AI in Quality Operations
AI agents in the deviation workflow, batch record review, GMP document drafting and QC data review: AI applied to the quality work that eats the most hours.
Validating AI Under GMP
Applying CSA and the GAMP AI guidance, setting acceptance criteria before go-live, and keeping models validated once they’re live.
AI on the Manufacturing Floor
Vision inspection, process models on continuous lines and predictive maintenance, qualified for commercial production.
Scaling Across the Network
Platform qualification, reusable validation packages, tech transfer to sites and CDMOs, and the data and funding that make scale possible.
Leadership & Adoption
Why pilots stall, how leaders get them into production, and how to bring operators and QA reviewers along.
OUR COMMUNITY
Past Attendees Include
May 11-12, 2027
Agenda Preview
- 7:15 – 8:15
Registration & Continental Breakfast
- 8:15 – 9:00
Opening KeynoteThe AI Factory: How Leading Manufacturers Broke Out of Pilot Purgatory
What the programs that reached validated production did differently, from choosing use cases to securing funding, and what stalled the rest. - 9:00 – 9:45
Regulator Keynote + Ask the RegulatorThe Regulator’s View: What Inspectors Expect When AI Runs Your GMP Process
How inspectors approach AI in GMP today, the evidence they ask for, and where draft Annex 22 and FDA guidance are heading. Ends with an open “Ask the Regulator” Q&A, so bring your questions. - 9:45 – 10:10
Networking Break · Exhibitor Showroom
- 10:10 – 10:50
AI Agents in the Deviation Workflow: From Triage to CAPA, With a Human Signing Off
How AI agents pull batch, equipment and lab data, draft the investigation and propose CAPAs, where the human reviewer stays in control, and how the workflow was validated for GMP use. - 10:50 – 11:30
Batch Record Review in Minutes, Not Days, and the Validation Package That Proves It
The review-by-exception approach, the time it saved, and the validation evidence that got it approved for commercial batches.
Speakers
Practitioners from leading life sciences companies. More speakers to be announced.
Who should attend
Built for the people who have to make AI work, and sign off on it, in a GMP environment
- Validation, CSV & CSA leaders
- Quality assurance & compliance
- QC & laboratory leaders
- Manufacturing, MS&T & engineering
- Digital, data science & IT quality
- Regulatory affairs & data integrity
- Site heads & operations leaders
- AI program & CoE leads
Group Pricing
Bringing 6 or more attendees?
Send your team for less. Tell us about your group and the KENX team will follow up with special group pricing for AI in GxP: Pilot to Production to Scale.
Group pricing
Tickets
Need approval to attend?
Download a justification letter
A ready-to-send letter for your manager with key sessions, takeaways and pricing.
Venue & Travel
San Francisco.
May 11–12, 2027 · In person only
Venue and hotel room block details will be announced.
11 Events · North America & Europe
2027 Conference Schedule
Advance your professional development in the GxP and validation landscape.
Full agendas and registration coming soon at KENX.org
AI in GxP: Puerto Rico
Validation University
Process Validation & Equipment Qualification Across the Lifecycle, from the People Actually Doing It
AI in GxP: Pilot to Production to Scale
Real Deployments. Real Validation. Real Scale.
GxP Laboratory Summit
Analytical Methods, Data Integrity & Lab Modernization, from the People Running the Labs
CSV & CSA European Congress
Getting Ready for the New Annex 11: Risk-Based CSV & CSA in Practice
Sterility Assurance University
Contamination Control That Holds Up to FDA: CCS, Microbiology & Cleaning Validation
AI in GxP: Guardrails & Governance
Risk, Oversight, Model Monitoring, and Inspection Readiness for AI
GCP & Clinical Operations Summit
Making E6(R3) Work: Quality by Design, Vendor Oversight & AI in Clinical Trials
GMP & Quality Operations Summit
Inspection Readiness, Warning Letter Lessons & New-Site Startup, from the Quality Teams Living It
AI in GxP: Europe
Annex 22, Annex 11 & the EU AI Act, in the Heart of Europe’s Pharma Industry
CSV & CSA University
Less Paperwork, More Assurance: Making the Move from CSV to CSA
Who should attend?
Professionals in pharmaceutical, biotech, MedTech and CDMO organizations who deploy, validate, scale or approve AI in GMP operations.
Is there a virtual option?
No. AI in GxP: Pilot to Production to Scale is an in person only event in San Francisco, CA on May 11-12, 2027.
What's included in my pass?
Access to all sessions across both days, the exhibitor showroom, breakfast, lunch, networking refreshment breaks and the networking reception.
Are group rates available?
Yes. Registering 6 or more attendees? Use the group pricing form to request special group pricing.
What's the cancellation policy?
KENX does not issue refunds. If you are unable to attend after registering, we are happy to apply your registration fee toward a future KENX event or transfer your registration to a colleague. All cancellation or transfer requests must be received at least seven days prior to the event.
How do I become a sponsor or exhibitor?
Use the Become a Sponsor or Become an Exhibitor links, or contact the KENX team to discuss opportunities.
Please Note: KENX does not issue refunds. If you are unable to attend after registering, we are happy to apply your registration fee toward a future KENX event or transfer your registration to a colleague. All cancellation or transfer requests must be received at least seven days prior to the event.
