CSV - Data Integrity
Master CSV & Data Integrity compliance with expert-led, GxP-focused training.
Service Description
This training provides a solid understanding of regulatory requirements related to computer system validation (GAMP 5) and data integrity (ALCOA+ principles). Learn how to implement a compliant lifecycle approach to computerized systems, ensuring both performance and audit-readiness. Learning objectives: - Understand the foundations of CSV and Data Integrity regulations (FDA, EMA, GxP) - Apply a risk-based approach to system validation throughout its lifecycle - Identify and manage data integrity risks across digital processes - Prepare for audits and inspections with confidence Target audience: Quality Assurance, IT, Validation, Regulatory Affairs, Project Managers Format: On-site or remote – 1 full day
Contact Details
Avenue Edison 8, Wavre, Belgium
+32491941279
camille.lojou@ellion.be