Introduction to this course: 

This course covers the strategy for assessing, analyzing, and reviewing risks within a quality risk management framework. It explores the pillars of risk strategy and principles specific to Quality Risk Management, designed for life sciences professionals. Gain insights and best practices aligned with compliance guidelines such as ICH Q9, ISO 9001, ISO 31000, ISO 13485, and ISO 14971.

Who should attend: 

This course is designed for both beginners and seasoned professionals seeking to deepen their knowledge and apply effective risk management strategies: QA/QC, regulatory affairs, manufacturing and production, compliance, and auditors.

Learning Outcomes: 

By the end of this lesson, you will be able to:

• Identify key concepts and terminology related to Quality Risk Management in the life sciences industry.

• Explain the principles and importance of risk management, including the distinction between positive and negative risks.

• Implement basic risk assessment and risk control techniques in a simulated or real-world life sciences context.

• Evaluate potential risks in manufacturing processes and determine appropriate mitigation strategies.

What will I gain: 

Participants will gain through understanding of Quality Risk Management principles and strategies specific to the life sciences industry. They will also acquire practical skills in assessing, analyzing, and controlling risks to ensure compliance and enhance organizational performance.

Prerequisites: 

Prerequisites for this course include a basic understanding of quality management systems and processes in the life sciences industry. Familiarity with fundamental concepts of risk management and relevant ISO standards is also recommended.

Additional information: 

Course duration: 02:24:10

Course code/version (effective date): L-71/v1.0 (29/09/2023)