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Handling Product Complaints and Recall

Handling Product Complaints and Recall

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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.

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