- Save the Date · Sep 28-29, 2027
- Conference
AI in GxP: Guardrails & Governance
Risk, Oversight, Model Monitoring, and Inspection Readiness for AI
- Sep 28-29, 2027
- Boston, MA
Special Rate ends December 31
Need approval? Download a justification letter
Overview
Trust, but Verify. Then Document It.
AI is already influencing deviations, batch review, and document workflows. Governance has to keep pace. That means a risk framework, a validation approach for models that change, monitoring that catches drift, and evidence an inspector will accept.
Built for oversight
Every session addresses a control question: how to classify AI risk, how to validate a model, how to monitor it in use, who is accountable, and what to show an inspector.
From the people doing it
You will hear from quality and validation leaders who have built AI governance programs inside manufacturers and sponsors, and leave with frameworks you can adapt right away.
Outcomes
What you'll leave with
AI Risk Management
Classifying AI use cases by risk, setting intended use, and right-sizing controls for GxP impact.
Validating AI
Applying CSA, GAMP 5 Second Edition, and the GAMP AI guidance to machine learning and generative AI, including performance criteria and test sets.
Model Monitoring & Lifecycle
Detecting drift, managing retraining and change control, and deciding when a model needs to be revalidated.
Human Oversight & Accountability
Defining human-in-the-loop roles, decision rights, and the governance structure that owns AI risk.
Supplier & Third-Party AI
Qualifying vendors whose products embed AI and keeping oversight when the model isn't yours.
Inspection Readiness
What auditors and inspectors ask about AI today and how to document and defend AI-enabled processes.
Who should attend
Built for the People Who Have to Control AI.
- AI Governance and Risk Leads
- QA, Compliance, and Audit Managers
- Regulatory Affairs and Compliance
- VP, Director, and Head of Quality
- Chief Digital, Data, and Information Officers
- CSV and CSA Managers and Specialists
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 the AI in GxP: Guardrails & Governance.
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
Boston, MA
Sep 28-29, 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?
This event is designed for professionals in Pharmaceutical, Biotech, MedTech, CDMO, CRO
Is there a virtual option?
No. AI in GxP: Guardrails & Governance is an in person only event in Boston, MA on Sep 28-29, 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.
