ICH Q9(R1) Quality Risk Management (QRM) In-house Training

Course overview

Stay updated on the recent revisions to ICH Q9R1 Quality Risk Management by regulators and gain insights into its practical application in pharmaceutical manufacturing.

This training is crucial to understand the revisions made in response to regulatory observations of inadequacies in quality risk management processes, which have shown unjustified assumptions, unsystematic approaches, inadequate formality relative to risk, subjective evaluations, and potential impacts on product availability

Participants will be brought up-to-date with the latest requirements of Q9R1, understanding its changes and their implications for pharmaceutical products and processes across various situations and product types.

Engaging with experts in the field provides an ideal platform to grasp these recent updates comprehensively and discuss their practical implications.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines.

Benefits of attending

• Keep up to date with the changes
• Understand the implications on products and processes
• Discuss new terms such as subjectivity, uncertainty, importance and complexity
• Stay abreast of the latest thinking on Quality Risk Management (QRM)

Who should attend?

Anyone from the pharmaceutical industry or related academia who wants to ensure they are up-to-date with the latest thinking on QRM, including:

• Manufacturing, production management, and technical support functions
• Development scientists
• Engineers
• Regulatory departments
• Quality Assurance
• Supporting companies such as equipment suppliers and consultants