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.

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: 15/02/2023

Curriculum for this course

Course Overview
24 secs
What You'll Learn
31 secs
Front Desk Administrative Staff
57 secs
Head of Quality
1 min 18 secs
Subject Matter Experts
1 min 24 secs secs
Internal Inspection Team (IIT)
34 secs
Documentation Preparedness
35 secs
Organizational Preparedness
31 secs
General Preparedness
37 secs
The Inspector Binder
52 secs
Internal Inspection Team Roles
3 min 2 secs secs
Quick Knowledge Check
30 secs
Questioning Techniques
1 min 40 secs
Questions an Inspector Won't Ask
1 min 35 secs
What's Your Policy?
43 secs
Quick Knowledge Check
40 secs
Dont's
1 min 18 secs
Do's
1 min 32 secs
Body Language & General Behavior
15 secs
Look the Part
26 secs
Quick Knowledge Check
30 secs
What We Covered
32 secs

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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