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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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Quality Digest Live -- April 13, 2012

 
 

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