Complaint Handling and Recall Management

Patients and health authorities expect medicinal products and medical devices to be of high quality.
However, quality issues do occur, and it is important to have robust systems in place for investigating customer complaints and recalling products.
During GMP inspections, health authorities always focus on scrutinizing these processes, as they are essential components of ensuring patient safety.

During this course, you will learn how to establish robust and compliant processes for handling customer complaints and product recalls.

We will look at the complete process, from the first customer contact to the completion of the investigation and any necessary market action.

You will learn how to triage customer contacts into product inquiries, adverse events, and product complaints.

Furthermore, you will see examples of how to investigate specific customer complaints and recall products.

Your benefit

• You will understand the regulatory requirements for handling customer complaints and product recalls.
• You will see specific examples of handling customer complaints and product recalls.
• You will be able to implement compliant and robust processes for complaint handling and product recalls within your organisation.

Your company's benefit

• Your employee understands the regulatory requirements for handling customer complaints and product recalls.
• Your employee can help establish and improve processes for handling customer complaints and product recalls within the organisation.
• Your employee can explain these processes during authority inspections.