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: English
Final Exam: Yes
Certification: Yes
Version: V1.4
Effective Date: 02/15/2023

Curriculum for this course

Course Overview
What You'll Learn
Front Desk Administrative Staff
Head of Quality
Subject Matter Experts
Internal Inspection Team (IIT)
Documentation Preparedness
Organizational Preparedness
General Preparedness
The Inspector Binder
Internal Inspection Team Roles
Quick Knowledge Check
Questioning Techniques
Questions an Inspector Won't Ask
What's Your Policy?
Quick Knowledge Check
Dont's
Do's
Body Language & General Behavior
Look the Part
Quick Knowledge Check
What We Covered

Test Your Knowledge

Results

Minor update: Fix quiz attempts to a maximum of 3 attempts and fix a typographical error in a knowledge check.
V1.4
Course updated to improve quiz functionality.
V1.3
Course updated to improve course functionality.
V1.2

Author

Matt Peplowski

Owner & Principal, Biopharm Error Prevention Associates, Inc.

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