How Does Quality Pulse® Align with ICH Q10

Gorecki: Very well. Ken, do you want to take that first? Ray: Sure, I’ll take a stab at it. If you look at Q12 and some of the content that’s in Q12, it talks about risk management and... Read more

Quality Culture Scenarios – Good vs. Bad

It’s our belief that culture poses a direct risk to life science companies. And by understanding your culture and having a predictive diagnostic model that you can then do an assessment, see where your needed improvements are, target... Read more

The Scientific Basis of Quality Pulse®

Edgar Schein was a researcher in the 1950s and ‘60s in organizational dynamics and came up with a model that included what the organization says and what the organization does as principle drivers for creating a corporate culture.... Read more

A New Quality Culture Paradigm

These two slides date back almost 20 years, and the FDA intuitively saw that culture is tremendously impactful on the outcomes of life science companies, just as Teresa described. And they intuitively described, and empirically described, what they... Read more

What Are FDA’s Thoughts on Quality Culture?

I want to begin before I turn it over to Ken and talk a little bit about FDA’s thoughts on quality culture. I think this is one of the areas that I’ve seen FDA become more and more... 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. Still, many companies struggle to build strong, functional quality systems, instead creating various regulatory versions of the Winchester... Read more