Risk Assessment in GMP Environments

Overview

Risk Assessment in GMP Environments helps teams apply quality-risk-management principles more effectively in daily operations and decision-making. Through an interactive workshop format, participants practice structured tools such as risk matrices and FMEA with direct relevance to GMP expectations and environmental monitoring programs.

What participants will learn

• Understand the core principles of quality risk management under ICH Q9 (R1) and Annex 1

• Define and apply concepts such as hazard, severity, likelihood, and detection

• Use risk matrices and FMEA to structure decisions and prioritize action

• Conduct risk assessments relevant to environmental monitoring and sampling strategies

• Document risk-management activities in ways that support audits and cross-functional communication

Ideal audience: 

 Ideal for QA professionals, production teams, QC and environmental-monitoring staff, investigators, and employees involved in CAPAs or process improvement.  

Employer value: 

For employers, this course helps embed practical risk thinking into routine work, supporting stronger decisions before issues escalate.

Note: This course is the ideal complement to the GMP Readiness Accelerator for employees who will be involved in performing risk assessments.