FDA Inspection Readiness (GMP Auditing)

Inspection Readiness: Your Role & Preparing for Inspector Interactions

This course provides an overview of health authority inspection roles & responsibilities, what to expect when being questioned by an inspector, as well as inspection behavior expectations.

By the time you’ve finished this course, you’ll feel ready to play your part in an inspection and prepared to interact with inspectors.

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CEU Credits: 0.1

Course Code: ELM-191

Duration: 25 mins

Skill Level: Basic

Language: Chinese (Simplified), English, French (France), German, Italian, Japanese, Portuguese (Brazil), Spanish (Spain)

Final Exam: Yes

Certification: Yes

Version: V1.5

Effective Date: 02/15/2023

Curriculum for this course

Course Introduction

Course Overview

What You'll Learn

Inspection Roles and Responsibilities

Front Desk Administrative Staff

Head of Quality

Subject Matter Experts

Internal Inspection Team (IIT)

A Deeper Look at the IIT

Documentation Preparedness

Organizational Preparedness

General Preparedness

The Inspector Binder

Internal Inspection Team Roles

Quick Knowledge Check

Being Questioned by an Inspector

Questioning Techniques

Questions an Inspector Won't Ask

What's Your Policy?

Quick Knowledge Check

Interacting with Inspectors

Dont's

Do's

Body Language & General Behavior

Look the Part

Quick Knowledge Check

Conclusion

What We Covered

Test Your Knowledge

Results

Revision History

v1.5 Minor update on 02/25/2025. Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.

v1.4 Minor update on 06/03/2024 to fix quiz attempts to a maximum of 3 attempts and fix a typographical error in a knowledge check.

v1.3 Minor update on 08/23/2023 to improve quiz functionality

v1.2 Minor update on 06/14/2023 to improve course functionality

v1.1 Minor update on 02/15/2023 to fix assessment functionality

v1.0 Course released in 2021