- Conference
8th Annual
VALIDATION UNIVERSITY
Driving Excellence in Modern Validation & Qualification Processes
- Philadelphia, PA
- March 19-20
- Prices increase February 13!
Attend ViRtually or In-Person
Gold Sponsors
Overview
Validation is evolving fast — and Validation University 2025 equips life-science professionals to stay ahead. From lifecycle-based process validation to AI-driven testing, digital twins, and CSA implementation, this two-track program unites experts in quality, validation, engineering, and IT to share practical, risk-based strategies. Whether your focus is process and cleaning validation or CSV/CSA and facility qualification, every session delivers tangible insights aligned with the latest FDA and EU expectations.
What You’ll Learn
- Apply Computer Software Assurance (CSA) across systems, software, and documentation
- Implement controls aligned with QMSR and ISO 13485 ahead of 2026 enforcement
- Validate AI and adaptive software under the FDA’s final AI/ML guidance
- Build audit-ready documentation for cybersecurity, cloud platforms, and SBOMs
- Prepare for EU MDR/IVDR transitions and notified body expectations
- Translate real-world evidence (RWE) into regulatory submissions
- Comply with new LDT regulation beginning May 2025
- Connect design control, usability, and risk for stronger submissions
- Leverage supplier oversight dashboards and remote audit strategies
- Align your Part 11 compliance for modern, cloud-based environments
Special Features
- 45 + focused sessions across Process, Cleaning, CSV/CSA, Facility & Equipment
- Dedicated AI in Validation sessions featuring real-world use cases and emerging frameworks
- Hands-on workshops for paperless validation and CSA scaling
- Cross-disciplinary panels linking validation, engineering, and automation strategy
- Practical statistics and risk-based workshops to reduce cost and complexity
Who Should Attend
Professionals responsible for ensuring compliant, efficient validation programs, including:
- Validation Engineers and Managers
- QA/QC Specialists and Leads
- Process Development and Manufacturing Engineers
- CSV/CSA Leads and IT Quality Professionals
- Facility and Equipment Qualification Managers
- Regulatory Affairs and Compliance Officers
- Data Integrity and Digital Transformation Specialists
VENUE
Coming Soon
