Why Do FDA Inspections Often Turn Out Bad?

Why do good manufacturing operations have bad inspections? FDA warning letters and 483s are rife with references to manufacturing controls and batch failures; to SOPs and QC procedures; and to complaint handling and CAPA investigations. But in many,... 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

Writing: The FDA Compliance Problem No-One Talks About

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

A Two-Data-Point Measure of Manufacturing Quality Culture

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