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Email: info@kenx.org
Phone: 858 649 3251
- Conference
CSV & CSA University Europe
Modernizing Approaches Across Legacy, Cloud, and AI-Driven GxP Systems
- AMSTERDAM, NE
- June 2-3
Attend ViRtually or In-Person


Gold Sponsors
Overview
CSV & CSA University brings together experts across validation, quality, IT, and digital systems for two days of practical, implementation-focused training. The program emphasizes modern, risk-based approaches aligned with global expectations, including EU Annex 11, the emerging Annex 22 draft, and contemporary CSA principles for streamlining computerized system assurance. As organizations manage a mix of legacy platforms, cloud solutions, and AI-enabled technologies, attendees will gain real-world strategies, templates, and examples to strengthen compliance while modernizing validation practices across today’s evolving GxP landscape.
What You’ll Learn
- How to operate CSA while maintaining compliance across validation, quality, and IT
- Modern risk-based approaches that reduce documentation burden and accelerate system readiness
- Best practices for vendor audits, upgrades, SaaS/Cloud validation, mobile apps, automation, and digital systems
- Where emerging digital and AI capabilities fit into CSV/CSA frameworks, including governance, guardrails, and human-in-the-loop
Special Features
- Case studies from pharma, biotech, medical device, and digital health teams
- Step-by-step walk-throughs of templates, checklists, test scripts, and risk tools
- Sessions covering Data Integrity, audit trails, cybersecurity, and evolving regulatory expectations
- Two-track format to tailor learning across CSV fundamentals, CSA innovation, and AI-enabled approaches
- Validation, Quality, and Compliance Professionals
- IT, Automation, and Digital Transformation Leaders
- CSV/CSA Specialists, System Owners, and Project Managers
- QA Documentation, Data Integrity, and Audit Trail Review Teams
- R&D, Manufacturing, Process Development, and GxP Operations
- Anyone responsible for implementing or overseeing GxP computerized systems
The CSA/CSV University Conference was a great experience, there is a large range of topics discussed that I found to increase my own knowledge, but also gave me insights on how I can handle tasks at my current employment. There is a lot of insights into how to leverage AI to reduce costs, time and effort, and increase productivity for companies. As a younger professional (<5 years of experience), I would recommend attending this event.
I very much enjoyed the KENX CSV & CSA University. I attended virtually, and it was well worth the time and resources spent. Look forward to attending in the future!
Kenx conferences give you an opportunity to meet with industry leaders in a smaller environment, enhancing the networking opportunities. The topics are timely, targeted, and focused and I have been able to apply what I have learned immediately upon returning to the office.
