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
- Role of computerized systems in pharmaceutical development and production
- Types of systems: equipment, automated systems, and infrastructure
- Fundamental principles of computerized system validation
- Main regulations and guidelines applicable to CSV
- GMP requirements and their impact on computerized systems
- Health authorities’ expectations regarding IT compliance
- ALCOA+ principles and data integrity requirements
- Lifecycle stages of a computerized system
- Fundamentals of GAMP®5 and the risk-based approach
- Structuring a CSV project and defining roles and responsibilities
- Design and specification documents: URS, FS, and DS
- Risk analysis and validation planning
- Documentation and testing best practices
- IQ, OQ, and PQ activities within a CSV project
- Validation report preparation according to regulatory expectations
- Change management, deviations, CAPAs, and periodic reviews
- Continuity, security, and records management
- Decommissioning and data migration of computerized systems
Tarifs et aides financières
1 224 €
Formation catalogue planifiée chez aptaskil, avec un maximum de 25 % du groupe de participants issus d'une même organisation
Formation catalogue réservée à votre équipe, organisée dans vos locaux ou chez aptaskil selon vos préférences
Formation entièrement construite avec vous, adaptée à vos objectifs, votre contexte et vos besoins opérationnels
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.
