Learn how to establish robust processes for investigating customer complaints and performing product recalls.
Gain insights into regulatory requirements and practical examples to enhance compliance and inspection readiness of your organisation.
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 the handling of customer and product recalls.
We will look at the complete process from the first customer contact until completion of investigation and possible 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.
The course language is English.
At the course you will meet:
Erik Steffensen, Managing Partner and Principal Consultant, Spot-on Pharma Consulting.
The course covers the following topics, among other:
• Regulatory requirements for customer complaints and recalls
• Examples of customer complaint handling and product recalls
• How to establish robust and compliant processes for customer complaint handling and product recalls
The course will be a combination of interactive lectures and group work with cases.