The purpose of this course is to provide an overview of current good CSV practice along with some practical advice about how to achieve good outcomes in a cost-effective and resource-efficient way.
- Provide an overview of regulations and guidance relating to CSV
- An overview on how to apply CSV basics and practices for a successful CSV initiative
- Validation approach and considerations for CSV lifecycle
- CSV future developments including the drivers for GAMP5 Second Edition and Computer Software Assurance (CSA)
By completing/passing this course, you will attain the certificate Medical Device Certificate
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