Fundamentals Series

The Fundamentals of Inspection Readiness

This course will give you a fundamental understanding of inspection readiness in the life sciences. It will provide a framework of how to prepare, what to expect, and detail best practices for personnel interacting with inspectors.

At the end of this course, you’ll be able to:

  • Recall the different types of inspections
  • Identify the roles and responsibilities of personnel involved in an inspection
  • Recognize questioning techniques used by inspectors
  • Recall best practices and key ‘do’s and don’ts’ for interacting with inspectors
Book a Demo
CEU Credits: 0.1
Course Code: ELM-228
Duration: 15 mins
Skill Level: Basic
Language: Chinese (Simplified), English, French (France), German, Italian, Japanese, Portuguese (Brazil), Spanish (Spain)
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 25/01/2023

Curriculum for this course

Course Introduction
41 secs
Course Overview
18 secs
What You'll Learn
25 secs
Why Inspections are Important
1 min 35 secs
Pre-Approval Inspections
22 secs
Routine Inspections
22 secs
For Cause Inspections
31 secs
Typical Areas of Focus
56 secs
Reviewing Procedures
38 secs
Record and Document Review
45 secs
Internal Inspection Team (IIT)
1 min 17 secs
Front Desk Administrative Staff
53 secs
Head of Quality
1 min 6 secs
Subject Matter Experts (SME's)
1 min 2 secs
What to do When Interacting with an Inspector
1 min 49 secs
What Not to do When Interacting with an Inspector
1 min 4 secs
Being Questioned by an Inspector
1 min 34 secs
What's Your Policy?
13 secs
Inspection End
39 secs
After the Inspection
56 secs
Inspection Tips
39 secs
One
32 secs
Two
23 secs

Summary

What We Covered
28 secs

Test Your Knowledge

Results

Updated to improve content/clarity.
V1.1

Author

Matt Peplowski

Owner & Principal, Biopharm Error Prevention Associates, Inc.

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