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
Category: Achieving Compliance
Visualizing Quality Culture Data – Analyzing Two Quality Culture Scenarios
Now let’s look at a third quality culture scenario, where you have a weak or ambiguous culture. Notice in this one that expressed values is a relatively low score, as is underlying assumptions. But you have very strong... 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 Low Cost, Seven-Step Approach to Reducing FDA Enforcement Risk
August: normally full of summer… sun, sand and surf. As the song goes, “summertime and the living is easy…” In 2020, COVID-19 — and more recently its Delta variant — wreaked havoc on an orderly return to business... 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
