Setting up for long-term success
Questions linger about FDA processes that seem to favor medical device companies
Confronting the fear of being displaced by machines
The velocity at which digital transformation is reshaping business models seems utterly chaotic in a compliance-based industry
Huge amounts of biometric, DNA, and diagnostic data enable personalized medicine. They also enable unscrupulous and discriminatory marketing.
A cloud-based QMS can help address common international standards and regulations
Particularly in regulated industries, you really do want to know what goes into the sausage
A primer for life science manufacturers
A timeline of FDA and Sparta System activities
Easing regulatory compliance
A concise history of FDA’s risk-based Site Selection Model
What can we learn from the organizational cultures of different industries?
In this episode: China trade and a demo of web-based management system software
Three great guests
ISO vs. FDA audits, Baldrige winners, and what we can learn from GE
How BioBridge Global leverages a digital QMS in the heavily regulated world of regenerative medicines
From digital submissions to integrated document control, the agency moves into the lean arena
By scaring off small medical-device companies, Canada could limit number of important and innovative products
For answers to some troubling life-science questions, ask a quality professional
Finch Therapeutics forges a QMS for a life-saving treatment not yet approved by the FDA