About this Event
8th ANNUAL VALIDATION UNIVERSITY
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 risk-based process validation across modern manufacturing environments
- Implement Computer Software Assurance (CSA) throughout digital and automated systems
- Execute effective cleaning validation and contamination-control programs under Annex 1
- Strengthen Data Integrity and audit trail management across cloud and hybrid platforms
- Integrate digital twins and AI tools to improve process and equipment qualification
- Manage change control and deviation investigations with automation and traceability
- Bridge analytical method and process validation for stronger lifecycle control
- Design and maintain facility and utility qualification programs ready for Annex 22
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
Co-Located with the Pharmaceutical Engineering Summit
Expand your experience by joining the Pharmaceutical Engineering Summit — a dedicated track for automation, facility design, and process engineering professionals. Explore how digital twins, AI, and real-time analytics are transforming CQV, commissioning, and maintenance.
Event Venue & Nearby Stays
San Diego, CA, USA, United States
USD 1346.25 to USD 1995.00
