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Janet Woodcock
The staff of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) always tries to utilize cutting-edge science and up-to-date process management, befitting our...
    Like any large company, a modern hospital has hundreds, even thousands, of workers using countless computers, smartphones, and other electronic devices that are vulnerable to security breaches, data thefts, and ransomware attacks. But hospitals are unlike other companies in two important ways. They...
    Last month I joined Eric Buhrens, CEO at Lean Enterprise Institute (LEI), to host a leadership team from Tel Aviv’s Sourasky Medical Center. They were on a study mission to many of Boston’s fine hospitals and were winding up their week with a visit to LEI. Early in the discussion, one of our guests...
    “I wish there was a way for the FDA to give me a heads-up about my stuff, prior to submission….” That sentiment was really the basis behind the U.S. Food and Drug Administration’s (FDA) presubmission tool, as I was discussing recently with medical-device quality assurance and regulatory affiars...
    So, the Quality Digest team is considering a transition to working remotely for the most part. I and two other associates already do. In part one of this series, I outlined my ad-hoc attempt at creating a computer work space at home. The result was not very pretty. As I said in part one, my home...

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