FDA Inspection Readiness (GMP Auditing)

General Inspection Readiness

Inspections are a vital mechanism health authorities use to protect public health, by ensuring that firms are operating in a high state of control, producing safe and effective medicines, and maintaining robust quality systems.

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CEU Credits: 0.1

Course Code: ELM-190

Duration: 20 mins

Skill Level: Basic

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

Final Exam: Yes

Certification: Yes

Version: V2.2

Effective Date: 03/14/2023

Curriculum for this course

Course Introduction

Course Overview

What You'll Learn

Inspection Importance, Types and the Part you Play

Types of Inspections

Pre-approval inspection

Routine Inspection

For-Cause Inspection

Inspection Roles and Responsibilities

Administrative Professionals

Heads of Quality

The Internal Inspection Team

Other Personnel

Quick Knowledge Check

General Inspection Readiness

Procedures

Quality Culture

Inspection Prep Activities

The Inspection Process

What Will Inspections Review?

Lesson Learned

Inspection End

After the Inspection

Quick Knowledge Check

Conclusion

What We Covered

Test Your Knowledge

Revision History

v2.2 Minor update on 6/18/2025 to remove reference of FDA and 21 CFR. Course template enhanced to provide more specific quiz completion data and a Version History document.

v2.1 Minor update on 6/3/2024 to fix quiz attempts to a maximum of 3 attempts and fix a typographical error in a knowledge check.

v2.0 Minor update on 09/11/2023 to resolve quiz functionality issue