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.

CEU Credits: 0.1
Course Code: ELM-237
Duration: 25 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 03/04/2023

Curriculum for this course

Course Introduction
32 secs
What You'll Learn
41 secs
Risk Basics
1 min 29 secs
Risk in the Life Science Industry
54 secs
The ICH Q9 Document
1 min 36 secs
ICH Q9: Scope
28 secs
Principles of QRM
38 secs
QRM Teams
1 min 31 secs
General QRM Process
57 secs
Initiating a QRM Process
40 secs
Risk Assessment
2 min 5 secs
Risk Assessment Example
3 min 2 secs
Risk Control
1 min 36 secs
Risk Communication
54 secs
Risk Review
46 secs
Overview
1 min 24 secs
Formality in QRM
1 min 37 secs
Examples of Formality
1 min 33 secs
Risk-Based Decision Making
2 min 24 secs

Summary

What We Covered
50 secs

Test Your Knowledge

Results

Revision History

Author

Joanna Gallant

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