
Mock inspections: designing exercises that simulate real inspection conditions
Teaches the regulatory coordinator to design, execute, and debrief mock inspections that replicate the pressure, sequencing, and document-request patterns of FDA BIMO inspections and sponsor audits.
A mock inspection that does not feel real does not find real problems
There is a version of a mock inspection that goes like this: the regulatory coordinator sends an email on Monday announcing that a practice inspection will occur on Thursday. Staff spend Tuesday and Wednesday tidying binders, reviewing files, and rehearsing answers. On Thursday, the mock inspector asks polite questions, reviews documents that have been freshly organized, and produces a report noting a few minor formatting issues. Everyone feels reassured. And then three months later, an actual FDA Bioresearch Monitoring (BIMO) inspector arrives unannounced, requests documents the staff did not think to prepare, asks questions no one rehearsed, and identifies findings that the mock inspection never touched.