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
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: 01/25/2023

Curriculum for this course

Course Introduction
Course Overview
What You'll Learn
Why Inspections are Important
Pre-Approval Inspections
Routine Inspections
For Cause Inspections
Typical Areas of Focus
Reviewing Procedures
Record and Document Review
Internal Inspection Team (IIT)
Front Desk Administrative Staff
Head of Quality
Subject Matter Experts (SME's)
What to do When Interacting with an Inspector
What Not to do When Interacting with an Inspector
Being Questioned by an Inspector
What's Your Policy?
Inspection End
After the Inspection
Inspection Tips
One
Two

Summary

What We Covered

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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