- Register in 2026 for a Special Rate · Mar 30-31, 2027
- Conference
Validation & Qualification Summit
Process, Equipment, Facility & Computerized System Validation Across the Lifecycle, from the People Actually Doing It
- Mar 30-31, 2027
- Chicago, IL
Special Rate ends December 31
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.
Mar 30-31, 2027
Agenda
- 8:30 – 9:00
Registration, Continental Breakfast & Exhibitor Showroom
- 9:00 – 9:20
Chairperson's Welcome + Opening Remarks
- 9:30 – 10:10
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. - 10:20 – 11:20
Panel: Global 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. - 11:30 – 12:00
Networking Refreshment Break + Exhibitor Showroom
- 12:00 – 12:40
Choose between
Data Integrity Data Integrity in the Age of Autonomous SystemsExtending ALCOA+ to AI agents, synthetic data, and data volumes that exceed human auditing capacity.
Quality Risk Management ICH Q9(R1) in Practice — Formality Without the PaperworkApplying the “formality is a spectrum” principle to real risk-based decisions.
- 12:50 – 1:30
Lunch
- 1:40 – 2:20
Choose between
Inspection Readiness Are You Inspection Ready? Conduct a Gap Analysis of Your Validation ProgramA practical framework for finding — and fixing — gaps before an inspector does.
Equipment Qualification IQ/OQ/PQ Fundamentals: Master Risk-Based Equipment QualificationBack-to-basics grounding for teams building or refreshing a qualification program.
- 2:30 – 3:10
Choose between
Data Integrity Surviving a Data Integrity Audit: The Red Flags Inspectors Find in the First HourAnalytical Methods Bridging Analytical Method and Process ValidationEnsuring method reliability supports critical process decisions.
- 3:10 – 3:50
Networking Refreshment Break + Speed Networking + Exhibitor Showroom
- 4:00 – 4:40
Choose between
AI in GMP Annex 22 & the Limits of AI in Critical GMP OperationsWhat's allowed (static, deterministic models), what's excluded (LLMs, generative AI) — and why.
Utility Qualification Utility Qualification: Risk-Based HVAC, Water & Compressed Gas SystemsRight-sizing qualification scope for utility systems without over-engineering the paperwork.
- 4:50 – 5:30
Choose between
SUPPLIER QUALITY Creating an Effective Supplier Quality AgreementThe practical, contract-level companion to Annex 11's new supplier-oversight expectations.
SINGLE-USE SYSTEMS Validation of Single-Use Systems (SUS)Qualification strategies for biologics and cell/gene manufacturing platforms.
- 5:40 – 6:40
Panel Closing Forum: Engineering the Future Validation Function + Ask the Expert Open Floor
Roughly 15 minutes of moderated cross-disciplinary discussion on where the validation function is headed, then the floor opens — unscripted Q&A with a cross-section of the day's faculty. - 6:45 – 7:45
Networking Reception
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 & Qualification Summit.
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.
Past attendee
Chicago, Illinois
Venue to be announced
Venue & Travel
Chicago, March 30–31, 2027.
Venue and hotel details will be posted here once confirmed. Sign up for updates to be notified.
Speakers
Practitioners from leading life sciences companies. More speakers to be announced.
13 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 — West
Use Cases, Process Optimization, and Validation
Laboratory University & GxP Supply Chain Summit
Analytical Methods, QC Excellence, and GxP Supply Chain Resilience
GCP University
Modernizing GCP from Trial Conduct to Inspection Readiness
CSV & CSA University Europe
Ensuring Compliance and Integrity Across Traditional, Digital, and AI-Driven Systems
Sterility Assurance University
Advancing Microbiology, CCS, Cleaning Validation, EM, Digital Tools & Risk-Based Strategies Across the Lifecycle
AI in GxP — East
Use Cases, Process Optimization, and Validation
AI in GxP — Canada
Use Cases, Process Optimization, and Validation
GMP University & MedTech Validation Summit
Modernizing GMP and Medical Device Validation from Risk to Inspection
AI in GxP — Puerto Rico
Use Cases, Process Optimization, and Validation
AI in Clinical Operations & Clinical Trials
Validating and Inspecting AI Across the Clinical Trial Lifecycle
AI in GxP — Europe
Use Cases, Process Optimization, and Validation
CSV & CSA University
Ensuring Compliance and Integrity Across Traditional, Digital, and AI-Driven Systems
Who should attend?
Professionals responsible for validation, qualification and quality in regulated life sciences manufacturing, including validation and CQV engineers, QA and QC professionals, data integrity and CSV specialists, and regulatory affairs teams.
What's included in my pass?
Access to all sessions and tracks across both days, the exhibitor showroom, continental breakfast, lunch, networking refreshment breaks and the Day One 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 above. For 6 or more attendees, use the group pricing form to request special group pricing.
Where is the venue?
Validation & Qualification Summit 2027 takes place in Chicago, IL on March 30–31, 2027. Venue and hotel details will be announced.
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?
Use the Become a Sponsor link or book a call with the KENX team to discuss sponsorship 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.
