From 'Back' To 'Front': US FDA, Industry Experts Advise Device Manufacturers On Best Inspection 'War Room' Practices
This article was originally published in SRA
Executive Summary
Ever since the first US Food and Drug Administration inspection took place decades ago, medtech manufacturers have relied on so-called "inspectional war rooms" - spaces where subject matter experts and others work to fulfill investigator needs. But such back rooms can cause headaches for medical device firms and stretch out inspections if they select unsuitable workers to staff and manage them.