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New Steps to Facilitate Medical Device Innovation

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In recent days, the U.S. Food and Drug Administration (FDA) has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system.

Drug Manufacturing That Is Out of This World

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Liquid-liquid separation and chemical extraction are key processes in drug manufacturing and many other industries, including oil and gas, fragrances, food, wastewater filtration, and biotechnology.

The Importance of Documenting Enterprise QMS Process Requirements

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Inside Quality Digest Live for Jan. 19, 2018

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During last Friday’s episode of Quality Digest Live, we looked at the far-reaching implications of a prospective merger, previewed our latest webinar with DNV, considered the importance of fun at work, and inspected some interesting stereo microscopes from V

DNA Has Gone Digital. What Could Possibly Go Wrong?

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FDA, International Regulators Look at Common Challenges to Innovation

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DNV GL Healthcare and CoxHealth Partnership for Improvement

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Inside Quality Digest Live for Dec. 1, 2017

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During last Friday’s episode of QDL, we examined the potential of quality thinking to improve outcomes for people’s health, manufacturing, and workplace efficiency. Let’s take a look:

Three Stages of Quality Management System Implementation and Oversight

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If I could summarize in one page the most important lessons I have learned in pharmaceutical quality assurance over the last 40 years, this is it.

Inside Quality Digest Live for Oct. 27, 2017

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Nissan autonomous car prototype
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Our Oct. 27, 2017, episode of QDL looked at Ford, autonomous cars, and changes to FDA compassionate use rules.

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