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• W1499806586 abstract "Risks in healthcare have been abundantly documented and many efforts are invested in order to identify, assess and mitigate such risks. This chapter covers several areas related to risk management in drug manufacturing and healthcare delivery. First, it focuses on the quality of data on adverse events; that is, risks that have materialized. Next, it analyzes how much data is used in healthcare risk management. The chapter continues to discuss risk management of individual treatments and provides an in-depth example of dialysis of patients with end stage renal disease (ESRD). It focuses on the manufacturer of drug products and explains how audits can be used to mitigate risks in the quality of the delivered drug product. Finally, the chapter focuses on drug manufacturing plants and risk events relative to quality compliance with current good manufacturing practices (cGMP) mandated by the Food and Drug Administration (FDA) and other regulatory agencies. Controlled Vocabulary Terms risk analysis" @default.
• W1499806586 created "2016-06-24" @default.
• W1499806586 creator A5038915241 @default.
• W1499806586 date "2012-07-30" @default.
• W1499806586 modified "2023-10-15" @default.
• W1499806586 title "Risk Management in Drug Manufacturing and Healthcare" @default.
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• W1499806586 doi "https://doi.org/10.1002/9781119940012.ch6" @default.
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