- Save the Date · Dec 8-9, 2027
- Conference
CSV & CSA University
Less Paperwork, More Assurance: Making the Move from CSV to CSA
- Dec 8-9, 2027
- Philadelphia, PA
Special Rate ends December 31
Need approval? Download a justification letter
Overview
Less Paperwork. More Assurance.
FDA’s Computer Software Assurance approach asks manufacturers to focus effort on what affects product quality and patient safety. Most teams agree with the idea. Fewer have changed how they plan, test, and document. This university is built to close that gap.
Built as a university
Two days of practical, step-by-step sessions that take you through a CSA-based validation lifecycle, from risk assessment to test strategy to the final record.
From the people doing it
Instructors are validation and quality leaders who have moved their own programs to CSA, and they bring the templates, examples, and inspection experience to prove it works.
Outcomes
What you'll leave with
CSA in Practice
Applying critical thinking and intended use to decide how much assurance each system and feature needs.
Risk-Based Testing
Choosing between scripted, unscripted, and exploratory testing, and documenting each the right way.
Supplier Assessment
Using vendor documentation and audits to reduce duplicate testing without giving up control.
Digital Validation
Moving from paper to digital validation tools, and validating those tools along the way.
GAMP 5 Second Edition
How GAMP 5 Second Edition supports CSA, agile delivery, and modern system lifecycles.
Data Integrity & Periodic Review
Keeping systems in a validated state with audit trail review, change control, and periodic review.
Who should attend
Built for the People Who Have to Control AI.
- Heads of Validation and IT Quality
- Validation Engineers and Analysts
- CSV and CSA Managers and Specialists
- QA and Compliance Managers
- System Owners and Business Process Owners
- IT and Business Systems
- 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 CSV & CSA 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.
Venue & Travel
Philadelphia, PA
Dec 8-9, 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.
Is there a virtual option?
No. CSV & CSA University is an in person only event in Philadelphia, PA on December 8–9, 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.
