New DRAFT FDA Guidance Published Today – Nonbinding Feedback

Tommy McMaster |

Important DRAFT FDA Guidance issued today (dated 2/19/19 however) regarding "non-binding feedback" after FDA inspections of certain medical device establishments. Limited to statutory (FDARA 704) situations involving a "public health priority", "implicat[ion] of systemic or major actions" or... Read more

Seven Things to Consider When Selecting a Pharmaceutical Quality Consulting Firm

Tommy McMaster |

Selecting a pharmaceutical consultant to help your organization with GMP, quality and compliance concerns can be a daunting task for any Quality executive. This is especially true for new or smaller companies that do not have existing relationships... Read more

A Two-Data-Point Measure of Manufacturing Quality Culture

Jack Garvey |

With my professional experience starting point as a plant-floor engineer, I’ve spent more than my fair share of time in pharmaceutical, medical device and other regulated manufacturing operations.  Prior to forking my career in the direction of quality,... Read more