Terry Winchell

GCP Innovative Dynamics, LLC


The 3 Essential Factors Affecting FDA Inspection Outcome

March 30, 2016

This article focuses on the 3 essential factors that have a significant impact on the outcome of any inspection or audit. The author applies this primarily to GCP (Good Clinical Practice) inspections, but the principles are universal, being applicable to any government inspection such as the FDA (U.S. Food & Drug Administration) or industry QA (Quality Assurance) audit.