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Compliance 360° Part 7: Factors Feeding Your Inspection Cycle – A New Paradigm

Executive Summary

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this seventh installment, former US FDA investigations branch director Ricki Chase explains how new initiatives within the agency and center for devices – including FDA's in-the-works "program alignment" inspection initiative, may affect your facility audits. Also discussed: the Medical Device Single Audit Program (MDSAP), the joint FDA/Medical Device Innovation Consortium (MDIC) Case for Quality, and FDA's Voluntary Compliance Improvement Program (VCIP).

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