FDA Inspection Readiness (GMP Auditing)

Audit Execution

The planning is done. Now it’s time for the audit execution. Join a fictional expert audit team as they conduct a critical on-site inspection. This course provides the practical, tactical skills needed to execute a rigorous and defensible GMP audit, moving you beyond documentation and into evidence collection. You will learn to manage the audit’s lifecycle, from conducting the professional opening meeting to classifying findings in real-world scenarios as Critical, Major, or Minor based on the potential for patient harm.

Book a Demo

CEU Credits: 0.1

Course Code: ELM-124

Duration: 15 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V3.0

Effective Date: 11/06/2025

Curriculum for this course

Welcome

Course Introduction

Auditing Techniques

Horizontal and vertical auditing

Supplemental techniques

The Opening Meeting

The opening meeting

The site tour

Maintaining professionalism and safety

Types of GMP audits

Engaging personnel

Anya’s site tour

Collecting Evidence

Methods overview

Interviews

Record review

Observation

The conference room pilot

The daily wrap-up

Identify and Document Findings

Generate audit findings

Anya’s audit findings

Classifying audit findings

Audit Closure Meeting

The close-out meeting

Conclusion

Summary

Test your knowledge

Revision History

v3.0 Major Update on 03/05/26 This course has been redesigned. The redesign includes new learning objectives to align with updated content, as well as a new exam for those objectives. The visual design has been updated as well.

v2.1 Minor update on 03/04/2025 to begin course with navigation menu collapsed. Additionally, the course template was enhanced to provide more specific quiz completion data and a Version History document.

v2.0 Major update on 07/11/2024 to upgrade player and update name from “FDA Inspection Readiness – Part 3” to “How to Be an Effective GMP Auditor – Part 3”, add new final exam question to align with learning objectives and resource links.

v1.0 Course released in 2021