ICH Guidelines

ICH Q9(R1) Quality Risk Management

What changed in the 2023 revision, and how to determine the appropriate level of formality for a given risk assessment.

What this course covers

This course covers what changed in the ICH Q9(R1) 2023 revision compared to the original Q9, how to determine the appropriate level of formality for a given risk assessment, common risk management tools such as FMEA and HACCP and when each is appropriate, and Q9(R1)'s specific emphasis on reducing subjectivity in risk assessment outcomes.

Who this course is for

QA and risk management leads building or reviewing risk assessments
Anyone applying quality risk management across manufacturing, quality or supply decisions

What you'll learn

What changed in the ICH Q9(R1) 2023 revision compared to the original Q9
How to determine the appropriate level of formality for a given risk assessment
Common risk management tools, including FMEA and HACCP, and when each is appropriate
Q9(R1)'s emphasis on reducing subjectivity in risk assessment outcomes
How quality risk management integrates with ICH Q10's pharmaceutical quality system

Why it matters

Risk assessments that reach a predetermined conclusion, working backward from the answer a site wants, are a recurring inspection concern. Q9(R1)'s subjectivity-reduction focus exists specifically to address that pattern, and it changes what a defensible risk assessment needs to demonstrate.

Included in the full GMPify subscription

Completion certificate, PDF slide download, and access to the complete GMP course library from day one.

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