CEU Credits: 0.1
Course Code: ELM-232a
Duration: 20 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.7
Effective Date: 08/29/2022
Curriculum for this course
Content Warning
Course Overview
What You’ll Learn
Quality Risk Management Definition
What is ICH Q9?
QRM Principles
The Benefits of QRM
QRM in Action
Quality Risk Management (QRM) Quick Knowledge Check
General QRM Process
QRM Process Initiation
Risk Assessment
Risk Control
Output of the QRM Process
Risk Review
Risk Communication
Basic Risk Management Facilitation Methods
Advanced Risk Management Facilitation Methods
Quality Risk Management Process Quick Knowledge Check
Why is QRM Important?
Situation
Action
Outcome
Why QRM is Important Quick Knowledge Check
Conclusion
What We Covered
Test Your Knowledge
Certification
Minor update: Course updated to reflect changes in ICH Q9 (R1) and update to new navigation standards
V1.7
Updated course title
V1.6
Updated course to improve quiz question content and clarity
V1.5
Updated course title
V1.4