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?
