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
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
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
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
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
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
As someone with many years of experience working in and around FDA-regulated manufacturing operations, a recent LinkedIn post (March 2018) entitled “Why QUALITY Needs to STOP Working on COMPLIANCE” has really rankled me. Unfortunately, this is not the... Read more
The following is a redacted transcript of a live, conference call question and answer session conducted on 16 March 2018 with a leading investment advisory firm interested in the Akorn v. Fresenius merger litigation. Jack Garvey, CEO of... Read more
