Handling Product Complaints and Recall
In this eLearning course you will learn all relevant aspects of complaint handling and recall system as per current GMP requirements in the pharmaceutical industry.
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
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.
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.