Introduction to this course: 

This course covers key concepts, and essential strategies for effectively managing complaints, quality defects, and product recalls in the life sciences. It provides best practices for receiving, investigating, and acting on these issues and also discusses the importance of effective risk management and quality assurance in preventing and mitigating these issues.

Who should attend: 

This course is designed for quality assurance professionals, regulatory affairs specialists, and compliance officers in the life sciences industry. It is ideal for anyone responsible for ensuring product safety and regulatory compliance in pharmaceuticals, medical devices, and related industries.

Learning Outcomes: 

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

• Recall key principles of complaint handling and product recall procedures.

• Explain the significance of GxP guidelines in maintaining product quality and patient safety.

• Implement effective strategies for investigating and resolving quality defects and customer complaints.

What will I gain: 

Participants will gain knowledge in managing complaints, quality defects, and product recalls, ensuring adherence to regulatory standards, and enhancing public health protection in the life sciences.

Prerequisites: 

No specific prerequisites are required, though familiarity with basic concepts of quality assurance and regulatory compliance in the life sciences industry would be beneficial. 

Additional information: 

Course duration: 00:18:11

Course code/version (effective date): L-91/v1.0 (27/12/2023)