Just released from FDAnews — Investigations Operations Manual 2014 — the FDA’s own internal guidance on how to inspect a drug or device company. Know what the investigators look for — before they even get there.
FDA investigators have every right to ask questions of plant-level employees during their walk-throughs. All too often, these are the workers who might flub their answers because they're under-trained. Here's your solution. Surviving a Regulatory Interview: In the Facility is designed especially to help you train your lower level, non-SME staff on how to deal with FDA investigators.