- Conference
8th Annual
VALIDATION UNIVERSITY
Driving Excellence in the Next Era of Validation & Qualification Processes
- Philadelphia, PA
- March 19-20
- Prices increase February 13!
Attend ViRtually or In-Person
Top 10 Validation Challenges Life Sciences Teams Are Solving in 2026
Gold Sponsors
Overview
Validation is evolving fast — and Validation University 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
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
Co-Located with Pharmaceutical Engineering Summit 2026
Engineering and validation are converging and the Pharmaceutical Engineering Summit 2026 is where that integration takes shape. This focused program brings together process, automation, and facility engineers to share best practices in designing, commissioning, and qualifying modern GxP environments. From Automation Lifecycle Qualification (ALQ) to Utilities 4.0, predictive maintenance, and AI-driven facility monitoring, discover how engineering excellence drives compliance, sustainability, and operational performance.
VENUE
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.