The Winchester House of Quality

Jack Garvey |

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

Writing: The FDA Compliance Problem No-One Talks About

Jack Garvey |

There are no FDA regulations governing writing quality or clarity. FDA Investigators will never note “poor writing” as a 483 observation or warning letter citation. But when it comes to regulated manufacturing operations, the FDA’s rule of thumb is... Read more

The Secrets We Keep — FDA Data Integrity, Elizabeth Holmes, Theranos, Bad Blood and HBO’s “The Inventor?”

Jack Garvey |

By now, most everyone in FDA regulated industry is aware of Theranos, the Wall Street Journal’s John Carryrou, and his award-winning book Bad Blood: Secrets and Lies Inside a Silicon Valley Startup. But have you seen HBO’s new... Read more