Handling Product Complaints and Recall
In this eLearning course, you will learn all relevant aspects of complaint handling and recall systems as per current GMP requirements in the pharmaceutical industry.
- Defining complaints
- Types and classification of complaints
- Regulatory requirements for complaints and recall handling
- How to handle complaints- the complaint management process
- Recalls and types of recall
- The recall process
- Role of management in the recall process
- Mock recalls- how to perform effectively
Who is it for
This course is designed for all personnel involved in complaint handling and/ or recall activities at their company and all Responsible Persons (RP) in Quality functions. It also serves to provide a high-level understanding of complaints and recall systems to management personnel.
Why it matters
According to chapter 8 of the EU-GMP Guide, pharmaceutical enterprises must review all complaints and other information concerning potentially defective products carefully and according to written procedures. Complaint & recall management requires focused and time bound efforts to control the potential impact on patients and provide opportunities for improvements.