ICH

ICH Q9 – Risk Management Methods and Tools

In this course we are going to learn about some of the primary tools that we have available to us that can help us identify, analyze, and evaluate risks in quality in our industry. These tools and their descriptions can be found in the ICH Q9(R1) document.

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CEU Credits: 0.1
Course Code: ELM-238
Duration: 20 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 05/17/2023

Curriculum for this course

Course Introduction
What You'll Learn

Background: Risk Management Methodology

Risk Management Tools

Flowcharts
Process Maps
Cause & Effect
Fault Tree Analysis
Knowledge Check
Failsure Mode and Effects Analysis
Failure Mode
Hazard Analysis and Critical Control Points
Hazard Operability Analysis
Preliminary Hazard Analysis
Knowledge Check
Risk Ranking
RRF Example
Knowledge Check
Summary
What We Covered
Test Your Knowledge
v1.1 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.
v1.0 Course released on 10/23/2023

Author

Joanna Gallant

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