Internal Audit: Be Ready For FDA Inspections

Inside this White Paper

In the regulated life sciences industry, relying solely on internal audits is insufficient for FDA inspection readiness. This white paper emphasizes that true preparedness involves more than just documentation—it requires a well-orchestrated strategy encompassing mock inspections, defined team roles, and behavioral training. By detailing the functions of Inspection and Control Rooms, and outlining the responsibilities of key personnel such as Inspection Coordinators, System Owners, Escorts, and Scribes, the paper provides a comprehensive framework for managing inspections effectively. It also highlights the importance of proactive planning and continuous improvement to ensure compliance and protect patient safety. For organizations aiming to enhance their inspection readiness and foster a culture of quality, this resource offers practical insights and actionable strategies.