Events for Food and Drug Administration (FDA)

Compliance Boot Camp 2008 : Validation, Quality and Compliance Training

You'll learn:

* Which validation deliverables the FDA expects and what they should contain
* How to identify, document and report computerized system validation deviations
* How the FDA defines a systems risk and mitigation strategy that you can deploy
* Proactive steps you can take to avoid CSV and Part 11 Form 483s and warning letters
* The five supporting pillars required for effective CSV, including: system management and monitoring, system change management, risk management, vendor management and CSV methodology management
* Update on the new draft Part 11 regulation

View the Event

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