CEU Credits: 0.1
Course Code: ELM-122
Duration: 20 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V4.0
Effective Date: 04/03/2021
Curriculum for this course
A Brush of the Sleeve
What is a GMP Audit?
Why are GMP Audits Important?
Safety, Business, and Compliance
More Benefits of an Audit
Internal GMP Audits: Self-Inspections
Internal GMP Audits: Vendor Audits
External GMP Audits: Regulatory Audits
External GMP Audits: Customer Audits
Audit Flow
Spot That Audit!
Auditor Backgrounds
ISO Principles
How to be a Successful Auditor
The Auditing Toolbox
Personal Compatibility
Handling Difficult Situations
Under Pressure
Maintaining Quality and Safety
Test your Knowledge!
v4.0 Major update on 06/24/2025. This course has been redesigned. The redesign includes updated learning objectives and content. The visual design has also been updated.
v3.0 Major update on 05/19/2023 to fix quiz functionality issue.
v2.0 Major update on 07/19/2022. Course name changed to How to be an Effective GMP Auditor Part 1 to better reflect the course content. The course’s previous name was FDA Inspection Readiness Part 1. Additionally, the course player and various images throughout the course were updated.
v1.0 Course released in 2021