International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

ICH Q9 – Quality Risk Management

In this course, we’re going to look at the ICH Q9 and the QRM, or quality risk management, process. Throughout this course, we’ll review the steps of the ICH Q9 process and learn how it can help us in managing risks in the life sciences industry.  At the end of this course, you’ll be given a chance to show what you’ve learned through a 10 question assessment. Once you’ve finished the course, you will have a chance to provide feedback on the course and your experience with it.

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CEU Credits: 0.1
Course Code: ELM-237
Duration: 25 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.2
Effective Date: 04/03/2023

Curriculum for this course

Course Introduction
What You'll Learn
Risk Basics
Risk in the Life Science Industry
The ICH Q9 Document
ICH Q9: Scope
Principles of QRM
QRM Teams
General QRM Process
Initiating a QRM Process
Risk Assessment
Risk Assessment Example
Risk Control
Risk Communication
Risk Review
Overview
Formality in QRM
Examples of Formality
Risk-Based Decision Making

Summary

What We Covered

Test Your Knowledge

v1.2 Minor update on 02/06/2025 begin course with navigation menu collapsed. Additionally, the course template was enhanced to provide more specific quiz completion data and a Version History document.
v1.1 Minor update on 09/12/2024 to add review questions button to exam feedback page
v1.0 Course released in 2021

Author

Joanna Gallant

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