Risk Management

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Jon Speer
Believe it or not, paper is very expensive. Although the going rate for a ream of standard copy paper is only about 10 bucks, the expense of relying on paper for your medical device quality...
    After a patient has a heart attack or stroke, doctors often use risk models to help guide their treatment. These models can calculate a patient’s risk of dying based on factors such as the patient’s age, symptoms, and other characteristics. While these models are useful in most cases, they do not...
    In part one of this series, I said that I want to help my colleagues use their ISO 9001 implementation as a profit center and to turn risk-based thinking into risk avoidance. To do this I will share a set of tools that help evolve quality management into business management. These tools include...
    Biopharmaceutical manufacturing uses living cells to produce therapies that treat diseases like cancer, diabetes, and autoimmune disorders. Manufacturing medicine using biology presents different challenges from the traditional chemical manufacturing processes that stamp out identical pressed pills...
    In the context of our increasingly disrupted, globalizing, and multicultural world, quality leaders greatly appreciate the security and comfort of clear-cut strategic plans for the future. After all, following our in-the-moment intuitions frequently leads to business disasters, and strategic plans...

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