« Validation is not just testing. It is documented evidence that a system works as intended and remains in a validated state throughout its lifecycle. »
This training program has been designed to provide a comprehensive and practical understanding of validation principles in a regulated pharmaceutical environment.
By completing this training, participants will have acquired a structured knowledge of :
- The validation lifecycle and its key stages
- The qualification process : IQ, OQ and PQ
- The critical role of documentation and traceability
- Risk assessment methodologies and their application
- GMP compliance requirements and regulatory expectations
Beyond Knowledge — The QA Mindset
More than technical content, this training aims to develop the professional mindset required in Quality Assurance :Critical thinking, attention to details, systematic approach and compliance culture
Summary :
Abbreviations and Acronyms.
Section 1: introduction to validation.
Section 2 : Validation life Cycle et model V
Section 3: Key Validation documents.
Section 4 equipment and system Validation.
Section 5: Process Validation.
Section 6: Impact and Criticality Assessment.
Section 7: Handling Deviations During Validation.
Section 8: Analytical method Validation.
Section 9: Computer System Validation (CSV). page 45
Fichier PDF disponible Prochainement