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Leverage Learning Environments to Create Customer Value

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A couple weeks ago a consultant friend of mine, who coincidentally focuses his practice on lean in healthcare, was complaining about issues with his healthcare providers.

FDA Form 483 Observations and Warning Letters: What’s the Difference?

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If you’re a medical device company manufacturing Class II or Class III devices, you can expect to have the U.S. Food and Drug Administration (FDA) turning up for an inspection. It’s what happens after that inspection that we’re concerned with in this article.

Deep Learning AI Discovers Surprising New Antibiotics

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Imagine you’re a fossil hunter. You spend months in the heat of Arizona digging up bones only to find that what you’ve uncovered is from a previously discovered dinosaur.

Critical Data Elements and Data Quality

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We are currently living in the digital age and are drowning in an ocean of data.

Manufacturing Standards for Biopharmaceuticals

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Biopharmaceuticals, also known as biological drugs or biologics, are manufactured from living organisms, or contain living organisms that have been genetically engineered to prevent or treat diseases.

Handling Product Recalls and Product Liability Lawsuits

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The manufacturing industry, stock market, and new product development have really taken off in the past four years, and there’s a lot of focus now on moving offshore manufacturing back into the United States.

Fourteen Leadership Principles That Drive Amazon to Be Customer-centric

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During the last five years, a small number of organizations have been featured multiple times in my writing.

Hospital Rankings Hold Up

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Given the complexities of healthcare, do basic statistics used to rank hospitals really work well? A study co-authored by MIT economists indicates that some fundamental metrics do, in fact, provide real insight about hospital quality.

Technique Reveals Whether Models of Patient Risk Are Accurate

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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.

Bridging the ‘Valley of Death’ for U.S. Biomanufacturing

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Biopharmaceutical manufacturing uses living cells to produce therapies that treat diseases like cancer, diabetes, and autoimmune disorders.

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