Course Description:
This course is developed in reference to ICH Q9 – Quality Risk Management (QRM) and provides a structured approach to implementing QRM within a pharmaceutical quality management system. Participants will begin by reviewing the requirements for QRM as outlined in ISO standards and WHO guidelines. The course then explores the principles and general process of QRM, including risk identification, assessment, control, communication, and review.
The training also covers risk management methodologies and potential applications of QRM across laboratory and manufacturing operations, equipping participants with practical tools to evaluate and manage risks effectively.
Pricing varies. Please inquire for more info at https://go.usp.org/Services.
Upon completion of this course, you will be able to
- Understand the requirements for implementing QRM within a Quality Management System
- Explain QRM principles and processes
- Develop and implement QRM procedures effectively
- Evaluate risks to quality based on scientific knowledge and experience, and take actions proportionate to the level of risk
Who should participate:
- National regulatory authorities
- National control laboratories
- Private QC laboratories
- QC labs in manufacturing