Quality Culture Scenarios – Good vs. Bad

Ken Ray |

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®

Ken Ray |

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

Jack Garvey |

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