Advanced Computerized Systems Validation Workshop ( CSV)
The Advanced Computerized Systems Validation (CSV) Workshop provides a deep and practical understanding of how to validate computerized systems used in GMP-regulated environments. Participants will explore the complete lifecycle approach to CSV — from planning and risk assessment to execution, documentation, and maintaining a validated state.
This workshop bridges regulatory expectations such as EU Annex 11, FDA 21 CFR Part 11, and GAMP 5, emphasizing data integrity, system security, and audit readiness. Through real-life examples, templates, and validation case studies, participants will learn to implement effective, compliant, and sustainable validation programs for laboratory, production, utilities, and quality systems. For More -->