- Save the Date · Mar 31-1, 2027
- Conference
AI in GxP Puerto Rico
Predictive Quality, Real-Time Release & Automation on the Plant Floor
- Mar 31-1, 2027
- San Juan, PR
Special Rate ends December 31
Need approval? Download a justification letter
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.
Every session is grounded in manufacturing operations: predictive quality models, real-time release testing, automation and robotics, and the plant data and MES foundations they depend on.
You will hear from manufacturers on the island and beyond who have put AI into production at their sites, and you will leave with approaches you can take back to your own lines.
AI Across the Plant Floor.
Where AI fits in a modern manufacturing flow, and what the program covers at each step.
Plant Data
Historians, MES, LIMS, and equipment data, connected and contextualized.
Predictive Quality
Models that watch the process in real time.
Real-Time Release
Release decisions based on process data and PAT.
Automation & Robotics
Robots, vision systems, and autonomous handling in GMP areas.
What You'll Take Home.
Six themes. Every one grounded in real manufacturing sites.
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.
Agenda
Coming Soon.
Two days of case studies, practical sessions and panels are being finalized now. Be the first to see the full program when it's released.
Get the agenda first
Enter your work email and we'll send it the moment it's live.
Learn from the Teams Doing the Work.
Our faculty brings together manufacturing, quality, automation, and digital leaders from global manufacturers, emerging biotechs, and the regulatory community. Speaker announcements are coming soon.
Faculty is being finalized and will be announced shortly. Check back for updates.Why AI in GxP: Puerto Rico.
Practitioners, Not Pitches
Our speakers are drawn primarily from manufacturers and sponsors who do this work every day. Every session is vetted by an industry advisory board to keep the content practical and vendor neutral.
Case Studies with the Details Left In
Hear what worked, what failed, how long it took, and what the documentation actually looked like.
Small Enough to Talk to Everyone
A focused, in person audience means real conversations with speakers and peers, not a sea of badges.
Thirty Years of GxP Focus
KENX has served pharma, biotech, and MedTech compliance professionals for three decades. This is a community that speaks your language.
Leave with a Plan
Walk away with frameworks, templates, and contacts you can put to use the week you get back.
Built for the People Who Run the Plant.
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.
Functions
- Manufacturing and Operations
- Quality Assurance and Quality Control
- Validation and CQV
- Process Engineering and MS&T
- Automation and Controls Engineering
- IT/OT and Manufacturing Systems
- Data Science and Digital Transformation
Titles
- Site and Plant Leaders
- Directors and Heads of Quality, Validation, or Manufacturing
- Automation and Digital Manufacturing Leads
- Validation Managers and Engineers
- QA and Compliance Managers
Organizations
- Pharmaceutical
- Biotech
- MedTech
- CDMO
“A highly informative and practical conference that delivered real insights and actionable strategies. Truly worth attending.”
Venue & Travel
San Juan.
March 31–April 1, 2027 · In person only
Venue and hotel room block details will be announced.
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 Validation & Qualification Summit.
Group pricing
AI in GxP: Puerto Rico
Register by December 31, 2026 for a special rate: $1,495 per attendee ($500 off)
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. Register 4–5 attendees and receive an additional $100 off each ticket; add Group Rate tickets in the ticket calculator. For 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 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.
