Module 1.9 Audit Plan

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This module provides an overview of developing and finalizing an audit plan for REMS stakeholders, which ensures compliance with REMS requirements and supports the noncompliance plan submitted to the FDA. It outlines the key sections of an audit plan, how to define audit goals, determine stakeholder selection criteria, establish audit methodologies, and document findings and corrective actions. The module also covers best practices for reviewing REMS Supporting Documents, coordinating approvals within single or shared system REMS programs, and submitting the finalized audit plan to the FDA as part of the REMS submission process.