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This Week in Quality Digest Live
FDA Compliance Features
Mike Richman
Three great guests
Dirk Dusharme @ Quality Digest
ISO vs. FDA audits, Baldrige winners, and what we can learn from GE
Ryan E. Day
How BioBridge Global leverages a digital QMS in the heavily regulated world of regenerative medicines
Taran March @ Quality Digest
From digital submissions to integrated document control, the agency moves into the lean arena
Dirk Dusharme @ Quality Digest
By scaring off small medical-device companies, Canada could limit number of important and innovative products

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FDA Compliance News
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements
The FDA wants medical device manufactures to succeed, new technologies in supply chain managment
Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals
Strategic investment positions EtQ to accelerate innovation efforts and growth strategy
The FDA’s RMAT designation goes live

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Mike Richman

FDA Compliance

Inside Quality Digest Live for Nov. 10, 2017

Overcoming stress at work, the benefits of AS9100, and meaningless food labels

Published: Tuesday, November 14, 2017 - 12:00

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:

“What Really Causes Workplace Stress”

A multidisciplinary team of researchers at the University of Southern California are in the process of studying nurses as part of a 10-week project. Their results will not only tell us about the effects of stress in the workplace, but also how engineers can design and interpret experiments to improve many facets of the human experience.

Interview: Gene Morrison

Morrison is the global aviation, space, and defense program manager and AS9100 lead auditor for Intertek, as well as author of the article, “Aerospace Faces Challenges as Market Rapidly Expands.” Click here to register for the webinar he is presenting on this topic, “Elevating into the Aviation, Space, and Defense Industry,” coming up Nov. 16, 2017.

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

Yes, apparently “gluten-free” water is actually a thing, and people actually purchase it. This article from food scientist Brandon McFadden considers the absurdity of some food-labeling marketing strategies, and also asks us to consider the similarities between buying some lunch and buying a Lincoln.

Off-Script: Visual clues

Quality Digest CEO Jeff Dewar joined the show via Skype to give us his hot take on some visual hot messes. Seeing ain’t always believing.

Catch us again for another episode of Quality Digest Live this coming Friday, Nov. 17, 2017. You can watch us either on our home page or our dedicated player page. See you there!

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About The Author

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Mike Richman

Mike Richman is Quality Digest’s publisher.