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

A New Quality Culture Paradigm

Ken Ray |

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