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CSV - Data Integrity

Master CSV & Data Integrity compliance with expert-led, GxP-focused training.

8 hr
Price upon request
Avenue Edison 8, Wavre, Belgium

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

Let’s Shape the Future of Life Sciences Together

Contact us to learn how we can support your organization!

Office: Avenue Edison 8 - 1300 Wavre

HQ: Avenue Arnaud Fraiteur 15/23 - 1050 Brussels

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