FDA Inspection Readiness (GMP Auditing)

Fundamentals of GMP Auditing

Regular GMP Audits are an effective and powerful practice for safeguarding patients, products, and businesses. What are the different types of audits and their benefits, and how does an audit progress? What are essential skills and knowledge that effective auditors possess?  Through practical examples and real-world scenarios, learners will explore these questions and more in order to understand how well-run audits ensure compliance with quality standards.

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.
v1.0 Course released in 2021

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