FDA Compliance Article | Quality Digest

FDA, International Regulators Look at Common Challenges to Innovation

Inside Quality Digest Live for Nov. 10, 2017

QDL co-host Dirk Dusharme was on vacation for our Nov. 10, 2017, episode, but we ably covered for his absence with some thought-provoking stories and great guests. Let’s take a look:

‘Gluten-Free Water’ Shows Absurdity of Trend in Labeling What’s Absent

Three Stages of Quality Management System Implementation and Oversight

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

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

FDA Eases Application Process for Compassionate Use

Inside Quality Digest Live for October 20, 2017

We cover a wide range of topics on QDL most weeks, but our latest episode, from Friday, Oct. 20, 2017, provided a steady drumbeat of technological detail. Here’s what we chatted about:

Design Validation vs. Clinical Evaluation

Are Your Medical Devices Secure?

If your hospital or clinic uses a Windows 7-based version of a Siemens PET/CT or SPECT system, it could be vulnerable to attack by a relatively low-skill hacker, according to a July 26, 2017,

FDA Seeks Public Input on Modernizing Regulatory Framework

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