- Conference
COMPUTER SYSTEMS, SOFTWARE & AI VALIDATION UNIVERSITY EUROPE
Modernizing Approaches Across Legacy, Cloud, and AI-Driven GxP Systems
- Dublin, IE
- 2-3 June
Attend ViRtually or In-Person
Top 10 Challenges VALIDATION AND COMPLIANCE PROFESSIONALS are solving in 2026
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
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.