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This Week in Quality Digest Live
FDA Compliance Features
Jon Speer
As a medical device manufacturer, you can expect to be inspected
Dirk Dusharme @ Quality Digest
Huge amounts of biometric, DNA, and diagnostic data enable personalized medicine. They also enable unscrupulous and discriminatory marketing.
Nicole Radziwill
A cloud-based QMS can help address common international standards and regulations
Kelly Kuchinski
Particularly in regulated industries, you really do want to know what goes into the sausage
Mike Richman
A primer for life science manufacturers

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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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Profiles in Quality: Mike Micklewright, Part 3 of 3

Video Information

In part three of our interview with Mike Micklewright he compares continuous improvement to continual improvement.

 

He also discusses 5S and how that ties into the 5 Whys.

 

Finally, Micklewright shows us how 5S can be used to help others. He has set up a charitible organization for those companies who want to do something with the waste collected by thier 5S cleanup other than throw it away.

 

www.5SForCharity.org

 
 

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