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Regulatory Coordinator6 of 6
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Module 1: Lesson 1
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.
The problem was not that the site conducted a mock inspection. The problem was that the mock inspection tested the site's ability to prepare for an inspection, not its ability to withstand one. And those are fundamentally different capabilities. Preparation is a project -- a burst of effort with a defined endpoint. Withstanding an inspection is a state -- the continuous readiness that Module 1 established as the standard, and that the gap analysis methodology from the previous lesson is designed to measure.
This lesson teaches you to design mock inspections that test the state, not the project. The exercises you build here will be uncomfortable for your staff, and that discomfort is the point. A mock inspection that reveals nothing uncomfortable has almost certainly been designed to avoid discomfort rather than to identify vulnerability. I have watched dozens of mock inspections over the years, at sites ranging from four-study community practices to 30-study academic medical centers. The ones that produced real improvement were, without exception, the ones where something went wrong during the exercise -- where a coordinator could not locate a document, where two staff members gave conflicting answers to the same question, where a process that everyone assumed was working turned out to have a gap that no one had noticed because no one had tested it under pressure.
That is what you are building: a pressure test. And it begins with understanding what real inspections actually look like.
What you will learn
By the end of this lesson, you will be able to:
Regulatory Coordinator
Full course · Inspection Readiness and Regulatory Quality Management