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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.

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.

Recent Legislative Impacts to Telemedicine in Care Delivery

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Legislative support is growing for the reimbursement of care delivery via telemedicine.

Quality Digest Top Stories for 2019

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As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk management, from China trade to FDA regulations.

An Action Plan for Work-Family Balance

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Eric, a 40-something married father of three, runs a successful startup. Given his demanding career, he and his wife decided she would be a stay-at-home mum.

Medical Errors Still Harm Too Many People, But There Are Glimpses of Real Change

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In late November 1999, a TV producer called me about an alarming report that 44,000 to 98,000 A

Weekly Quizzes for Current Good Manufacturing Practices Training Credit

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Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit!

FDA’s Fast-Track Model for Software As a Medical Device Requires a Cuture of Quality

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Software as a medical device (SaMD) is a growing sector in medical device technology.

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