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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.

  • 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

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.

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