AI in GxP Puerto Rico
Gold Sponsors
Overview
AI Where the Product Is Made.
Plant-floor AI is moving fast. Predictive models flag deviations before they happen, process data supports real-time release, and robots take on work that used to be manual. The question is no longer whether it works. It is how to validate it, connect it to MES and plant data, and defend it to an inspector.
Outcomes
What you'll leave with
Predictive Quality
Using process and quality data to predict deviations, batch failures, and equipment issues before they happen, and deciding when a prediction is reliable enough to act on.
Real-Time Release Testing
Building the PAT, data, and control strategy behind real-time release, and what regulators expect to see before you rely on it.
Automation & Robotics
Robotics, autonomous inspection, and automated material handling in GMP areas, from qualification through day-to-day operation.
Plant Data & MES
Connecting historians, MES, LIMS, and ERP so AI has clean, contextualized data to work with, and keeping that data integrity intact.
Validating AI on the Plant Floor
Applying CSA, GAMP 5 Second Edition, and risk-based assurance to models that sit inside manufacturing processes.
Inspection Readiness
How to document AI-enabled manufacturing decisions and explain them clearly to FDA and other inspectors.
Mar 31-1, 2027
Agenda
- 8:00 – 8:30
Registration & Continental Breakfast
- 8:30 – 9:00
OPENING KEYNOTE Validation at an Inflection Point: CSA, Annex 11 & the Road to 2027
Where U.S. and EU expectations are converging, and what it means for validation strategy through 2027. - 9:05 – 9:45
PANELGlobal Regulatory Dialogue: FDA, EMA/PIC/S & Industry
The new rules for computerized systems and AI in GMP, discussed side by side by the people writing and living under them. - 9:50 – 10:20
Are You Inspection Ready? Conduct a Gap Analysis of Your Validation Program
A practical framework for finding and fixing gaps before an inspector does. - 10:25 – 10:55
Data Integrity in AI-Assisted Workflows: Traceability, Human Oversight, and Patient Risk
How AI-assisted workflows can introduce errors, how to maintain traceability to source records, and how to establish meaningful human review and accountability.
Who should attend
This program is built for professionals responsible for validation, qualification and quality in regulated life sciences manufacturing. Attendees in the following roles will especially benefit:
- Site and Plant Leaders
- Directors and Heads of Quality
- Automation and Digital Manufacturing Leads
- Validation Managers and Engineers
- QA and Compliance Managers
- Process Engineering and MS&T
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 Puerto Rico.
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 Juan, PR
March 31–April 1, 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 manufacturing, quality, validation, and digital professionals in pharmaceutical, biotech, MedTech, and CDMO organizations who are bringing AI and automation onto the plant floor.
Is there a virtual option?
No. AI in GxP: Puerto Rico is an in person only event in San Juan, PR on March 31–April 1, 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 link, or complete our sponsorship inquiry form at , and the KENX team will follow up with options.
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.
