- Save the Date · Jun 15-16, 2027
- Conference
CSV & CSA European Congress
Getting Ready for the New Annex 11: Risk-Based CSV & CSA in Practice
- Jun 15-16, 2027
- Dublin, Ireland
Special Rate ends December 31
Need approval? Download a justification letter
Overview
The New Annex 11 Is Coming. Is Your Program Ready?
The revised Annex 11 raises expectations for computerised systems across their lifecycle, from supplier oversight and data integrity to security and periodic review. Readiness starts with a risk-based program. One that applies critical thinking, makes use of supplier documentation, and spends effort where the risk is.
Outcomes
What you'll leave with
Annex 11 Readiness
What changes in the revised Annex 11, where most programs have gaps, and how to plan a realistic path to compliance.
GAMP 5 Second Edition
Critical thinking, agile delivery, and the updated GAMP 5 framework applied to real system lifecycles.
CSA in Practice
Risk-based testing, unscripted and exploratory testing, and right-sized documentation that holds up to EU and FDA inspectors.
Cybersecurity
Security controls, access management, and incident response for GxP systems as regulators treat security as a data integrity issue.
Supplier & Cloud Oversight
Qualifying SaaS and cloud providers, using supplier documentation, and keeping control of systems you don't host.
Data Integrity & Audit Trails
Audit trail design and review, periodic review, and data governance across the system lifecycle.
Jun 15-16, 2027
Agenda Preview
- 7:15 – 8:15
Registration & Continental Breakfast
- 8:15 – 9:00
Opening KeynoteThe AI Factory: How Leading Manufacturers Broke Out of Pilot Purgatory
What the programs that reached validated production did differently, from choosing use cases to securing funding, and what stalled the rest. - 9:00 – 9:45
Regulator Keynote + Ask the RegulatorThe Regulator’s View: What Inspectors Expect When AI Runs Your GMP Process
How inspectors approach AI in GMP today, the evidence they ask for, and where draft Annex 22 and FDA guidance are heading. Ends with an open “Ask the Regulator” Q&A, so bring your questions. - 9:45 – 10:10
Networking Break · Exhibitor Showroom
- 10:10 – 10:50
AI Agents in the Deviation Workflow: From Triage to CAPA, With a Human Signing Off
How AI agents pull batch, equipment and lab data, draft the investigation and propose CAPAs, where the human reviewer stays in control, and how the workflow was validated for GMP use. - 10:50 – 11:30
Batch Record Review in Minutes, Not Days, and the Validation Package That Proves It
The review-by-exception approach, the time it saved, and the validation evidence that got it approved for commercial batches.
Speakers
Practitioners from leading life sciences companies. More speakers to be announced.
Who should attend
Built for the people who have to make AI work, and sign off on it, in a GMP environm
- Computer System Validation and CSA
- Quality Assurance and Quality Systems
- IT and Infrastructure
- Data Integrity
- Information Security
- Regulatory Compliance
- Laboratory and Manufacturing Systems
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 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.
Venue & Travel
Dublin
June 15–16, 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 validation, quality, and IT professionals in pharmaceutical, biotech, MedTech, CDMO, and CRO organizations operating under EU GMP.
Is there a virtual option?
No. CSV & CSA European Congress is an in person only event in Dublin, Ireland on June 15–16, 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.
