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What would be the three most important components of a quality system to prevent this type of contamination and resulting outbreak?

In this scenario, the FDA investigates a meningitis outbreak.

Situation: There is a potentially deadly outbreak of meningitis that may be linked to an injectable steroid medication.

Instructions: Navigate to the FDA website (Links to an external site.), for an overview of the meningitis outbreak (Links to an external site.). Then, from the Northwestern Library, find a minimum of two articles that discuss the details of this outbreak. Discuss the scenario, including:

  • Who is responsible for this outbreak? Why?
  • How could this outbreak have been prevented? Which regulations were violated?
  • What would be the three most important components of a quality system to prevent this type of contamination and resulting outbreak?

 


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