ICH Q9 is one of the most referenced guidelines in pharma and one of the most misunderstood.
In this video, I break down what Quality Risk Management (QRM) actually is, how the process works, and how it is different from ISO 14971.
If you work in pharma, devices, or combination products, this is foundational.
Subhi Saadeh is the Founder and Principal at Let’s Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics, including leading and supporting combination product transformations across large organizations.
Key Topics
- What risk means in ICH Q9 (probability x severity)
- The full QRM process: initiation, assessment, control, communication, and review
- How to actually think through risk, not just document it
- Why supply disruption is a patient risk
- Key differences vs ISO 14971: planning, traceability, and verification
Timestamps
- 00:00 Welcome to ICH Q9
- 00:48 What is Risk in ICH Q9
- 01:44 Scope and Core Principles
- 03:21 Initiating QRM
- 05:09 Risk Assessment (Hazards, Likelihood, Severity)
- 07:27 Risk Control (Reduction and Acceptance)
- 08:46 Risk Communication and Review
- 10:04 ICH Q9 vs ISO 14971
- 11:51 Wrap Up
