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Medical Devices, Pharmaceuticals

Part 11 Electronic Records and Signatures Changes in Enforcement Policy

About the Course

Since the inception of Part 11, FDA has issued changes to the enforcement policy for electronic records and signatures. This online course describes how to implement the new changes of Part 11 enforcement. Topics in this eLearning course include: Key Changes, FDA Enforcement, and Unaffected Provisions. After completing this online training course, learners will be able to recognize FDA expectations for compliance with all applicable predicate rules.