Red Nucleus Training Institute

Providing on-demand training solutions

Clinical Audits & Inspections

~0.50 hrs | GCP - Deviation Investigations, RCA, CAPAs, & Audit Preparation

This on-demand module will help you understand what an audit is, what to do to prepare for an inspection, and how to appropriately respond to resulting observations.

Module Details

After completing this module, you will be able to:
• Compare the similarities and differences among the processes of auditing, inspecting, and monitoring
• Identify regulatory inspection expectations and processes
• Recall how to prepare for an inspection and how to execute this plan when an FDA investigator arrives
• Recognize the various inspection letter types

Features

• Audio narration with on-demand full-text transcript
• Module-level interactive learning exercises and
self-check questions
• Fully cited and sourced from a blend of Red Nucleus
best practices and global health authority regulations
and guidance
• Updated annually
• SCORM compliant

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