Computerized System Validation (CSV) (EN)
Understand the challenges of computerized systems validation in a GxP environment and its link to data integrity. You identify key requirements and ensure system compliance.
- Biopharmaceutique - procédés et qualité
- Seneffe
- 3 days
- 12 people max.
- Alphacademy
- Entreprise
- Présentiel, Anglais
Before you register
Target audience : Personnel involved in the validation of computerized systems in a pharmaceutical environment: QA, IT, automation engineers, qualification and validation specialists, process owners, and production managers
Prerequisite : Basic knowledge of the pharmaceutical environment and quality processes is an asset
Learning objectives
- Identify applicable regulatory requirements and guidelines, including GAMP 5 and 21 CFR Part 11
- Explain the complete lifecycle of a computerized system in the pharmaceutical industry
- Apply a risk-based approach to structure a compliant validation strategy
- Develop the main CSV deliverables (URS, risk analysis, IQ/OQ/PQ protocols, validation report)
- Implement best practices for the operational management of computerized systems and data integrity
Training content
Introduction to Computerized System Validation
- Role of computerized systems in pharmaceutical development and production
- Types of systems: equipment, automated systems, and infrastructure
- Fundamental principles of computerized system validation
International Regulations and Standards
- Main regulations and guidelines applicable to CSV
- GMP requirements and their impact on computerized systems
- Health authorities’ expectations regarding IT compliance
Data Integrity and CSV Fundamentals
- ALCOA+ principles and data integrity requirements
- Lifecycle stages of a computerized system
- Fundamentals of GAMP®5 and the risk-based approach
Case Study: Design Phase
- Structuring a CSV project and defining roles and responsibilities
- Design and specification documents: URS, FS, and DS
- Risk analysis and validation planning
Case Study: Validation and Qualification Phase
- Documentation and testing best practices
- IQ, OQ, and PQ activities within a CSV project
- Validation report preparation according to regulatory expectations
Operational Phase and Decommissioning
- Change management, deviations, CAPAs, and periodic reviews
- Continuity, security, and records management
- Decommissioning and data migration of computerized systems
Fonds de formation du secteur chimie, plastiques et sciences de la vie qui finance les formations des collaborateurs des CP 116 et 207
Fonds de formation du secteur agroalimentaire qui finance les formations des collaborateurs des CP 118 et 220
Cette formation vous intéresse ?
La formation n'est actuellement pas programmée en inter-entreprise. Si vous souhaitez vous former vous ou vos collaborateurs, notre équipe peut organiser cette formation en intra-entreprise ou l'adapter à vos besoins spécifiques.
