Validation University

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.

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