FDA complaint handling training

A complaint is a written form of objection to a medical device or pharmaceutical product from the user. It is a signal that the product is not fully serving its intended use. To ensure that a product meets its intended use, the FDA has set out regulations for complaint handling. FDA complaint handling training is one of the primary hallmarks of complaint handling.

What is the purpose of FDA complaint handling training?

A good complaint handling system has to ensure that the product ensures a high level of patient safety. The complaint handling system should be seen more as a Return on Investment (ROI) than as an unpleasant problem that needs to be addressed. Having a proper complaint handling system will also make sure that pharmaceutical product companies do not attract lawsuits. FDA complaint handling training is the tool with which an organization can accomplish all these.

Importance of training

The FDA requires trained staff to be at the helm of matters throughout the complaint handling process. This explains the importance of FDA complaint handling training. Section 820.25(b) makes it “…the manufacturer’s responsibility to ensure that personnel are properly trained to adequately perform their duties. These employees shall have the proper education and training to process complaints. Any difficulty noted in employees performing required tasks for proper complaint handling may be an indication that additional training is needed. Training shall be documented.”

Protocol

The FDA complaint handling training attaches high importance to protocol. It clearly states that manufacturers should comply with the Medical Device Reporting (MDR) regulation, 21 CFR Part 803. It has clear rules on the following areas of complaint sources:

  • Who Must Report
  • When to Report

FDA complaint handling training will equip the personnel assigned the task of complaint handling to carry out:

  • Defining the complaint-handling process
  • Documenting the steps to receive, review, and evaluate complaints.
  • Implementing the procedures by proper employee training.

Reference:

http://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/qualitysystemsregulations/medicaldevicequalitysystemsmanual/ucm122686.htm

http://www.advamedmtli.org/download/File/Susan_Jacobs_Complaint_Sitting_System_23JAN08.pdf

http://www.mddionline.com/article/streamlining-complaint-handling-process

 

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