A Two-Data-Point Measure of Manufacturing Quality Culture

With my professional experience starting point as a plant-floor engineer, I’ve spent more than my fair share of time in pharmaceutical, medical device and other regulated manufacturing operations.  Prior to forking my career in the direction of quality,... Read more

POPULAR SCIENCE; BAD JOURNALISM

Two months ago I posted in LinkedIn about a Popular Science article that unfairly characterized FDA’s regulatory process, and implied FDA tacitly agreed with a company’s characterization of what can best be considered a sham product as a... Read more

The Winchester House of Quality

Well designed and executed quality systems are the foundation of compliance for the highly regulated pharmaceutical and medical device industries. But many companies struggle to build strong, functional quality systems, instead creating various regulatory versions of the Winchester... Read more