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
Compliance, quality, and serving the patient
ISO 45001 marks a significant step in the overall effort to improve OH&S standards worldwide
Regulatory work must keep pace with emerging cancer therapies
Understanding cultural issues that help or hurt organizational performance
