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Computer System Validation (CSV), or Software Validation, is a critical regulatory requirement mandated by Health Canada, the FDA, and the European Union. It ensures that computerized systems used in regulated industries perform consistently and reliably according to their intended purpose.
This workshop offers a comprehensive introduction to CSV principles, providing participants with the knowledge and tools to meet regulatory expectations throughout the life cycle of a computerized system. From understanding validation protocols to applying the GAMP 5 framework, participants will explore how to design, test, and maintain systems that are compliant, inspection-ready, and efficient in real-world operations.
The session will also examine the phases of the System Development Life Cycle (SDLC), the V-model approach, and the preparation of essential deliverables such as validation plans, test protocols, and reports. By combining regulatory insight with practical application, this training bridges theory and practice for professionals responsible for system validation in Pharma, Medical Devices, Logistics, and Warehousing.
Join us to gain a deeper understanding of the regulatory landscape, strengthen your audit readiness, and build confidence in maintaining validated systems that meet international standards. | 
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