Validation University
Gold Sponsors
Topics
Eight topic areas across two days.
Pick a topic to jump straight to its sessions in the agenda.
CSA & the Revised Annex 11
Where U.S. and EU expectations for computerized systems now converge.
AI in GMP: Annex 22
What AI is allowed in critical GMP operations, and what is excluded.
Equipment Qualification: IQ/OQ/PQ
Risk-based qualification for teams building or refreshing a program.
Utility Qualification: HVAC, Water & Gases
Right-sizing scope for utility systems without excess paperwork.
Data Integrity & Audit Trails
Maturity models and audit trail review your team can sustain.
Facility Design & Commissioning
Building compliance-ready regulated facilities for a digital future.
Continued Process Verification
Turning ongoing production data into Stage 3 action.
Digital & Paperless Validation
Selecting and scaling a digital CQV platform.
Overview
Validation in the Age of Convergence: CSA, Annex 11 & AI
Validation University 2027 brings validation, qualification and quality professionals to Chicago for two days on where U.S. and EU expectations are converging, from CSA and the revised Annex 11 to Annex 22 and AI in GMP, and what that means for validation strategy. Most sessions run as two parallel tracks, so you choose between topics such as data integrity, quality risk management, equipment and utility qualification, analytical methods, digital validation and cell & gene therapy. Regulator and industry panels open and close each day.
Outcomes
What you'll leave with
A clear read on 2027 expectations
Where FDA, EMA and PIC/S expectations for CSA, Annex 11 and Annex 22 now stand, and what they mean for your program.
Right-sized qualification
Risk-based approaches to IQ/OQ/PQ, utility and facility qualification that cut documentation without cutting compliance.
Stronger process validation
Practical methods for Stage 3 continued process verification, cleaning validation and method-to-process alignment.
Inspection-ready systems and data
Audit trail review, data integrity maturity and supplier oversight practices you can put in place right away.
A roadmap for digital and AI
What to check before adopting paperless CQV, digital twins or AI, and how to validate them defensibly.
Answers from regulators and peers
Open Q&A with regulators and faculty, plus connections with validation leaders facing the same challenges.
Apr 20-21, 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.
Speakers
Practitioners from leading life sciences companies. More speakers to be announced.
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:
- Validation Engineers
- Commissioning, Qualification & Validation (CQV) Professionals
- Quality Assurance Professionals
- QC & Analytical Scientists
- Data Integrity & CSV Specialists
- Engineering & Facilities Teams
- Manufacturing Science & Technology (MS&T)
- Regulatory Affairs 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 Validation University.
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.
Chicago, Illinois
Venue to be announced
Venue & Travel
Chicago, Apr 20-21, 2027.
Venue and hotel details will be posted here once confirmed. Sign up for updates to be notified.
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 responsible for validation, qualification, and quality in regulated life sciences manufacturing. This includes validation and CQV engineers, CSV/CSA and IT compliance leads, QA and QC professionals, data integrity specialists, engineering and facilities teams, MS&T, and inspection readiness leads.
What's included in my pass?
Access to all sessions on both days, the event compendium, and the exhibitor showroom. It also includes continental breakfast, lunch, and refreshments each day, the Day 1 networking cocktail reception, and a chance to win raffle prizes.
How much does it cost, and when do rates change?
- Special 2026 Pre-Registration rate: $1,495, through December 31, 2026. That’s $500 off the regular rate.
- Early Bird: $1,795, from January 1 through March 5, 2027.
- Regular rate: $1,995.
Are group rates available?
Yes. Registering 6 or more attendees? Use the group pricing form to request special group pricing.
Is this a single-track program?
Yes. Every session takes place in one room, so you never have to choose between sessions. The program runs from the opening keynote on Day 1 to the closing Q&A on Day 2.
Can I attend virtually?
No. The Validation University is an in-person event only.
Where and when is the event?
Validation University 2027 takes place April 20–21, 2027 in Chicago, IL. Registration and continental breakfast open at 8:00 AM Central Time each day. Venue and hotel room block details will be announced.
I’m traveling from outside the United States. What should I know?
Chicago is served by O’Hare International (ORD) and Midway International (MDW). Check U.S. entry requirements (visa or ESTA) well before you book travel, as processing times vary by country.
How do I get approval from my manager?
Download our ready-to-send justification letter. It covers the dates, cost, and what’s included, so you only need to add your details.
What is the cancellation policy?
KENX does not issue refunds. If you are unable to attend after registering, your registration fee can be applied to a future KENX event or transferred to a colleague. Cancellation or transfer requests must be received at least seven days before the event.
How do I become a sponsor?
Use the Become a Sponsor link, or complete our sponsorship inquiry form at kenx.org/sponsorship-inquiry, 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.
