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 election of Donald Trump as President-Elect of the United States was, and continues to be, a watershed moment in the 200+ year American experiment. The public, the business community, and government are all currently adjusting to a... Read more
I worked for a Chief Quality Officer a number of years ago who always had this response when our company was contemplating movement of a large volume of internal production to third parties: “You can delegate your responsibilities... Read more
Early December is one of my favorite times of year. Coming off of Thanksgiving and looking forward to the end-of-year holidays, it’s when I get to reflect on the past 12 months, and think about what the next... Read more
The September 12 edition of the industry newsletter QMN Weekly contained an article about objections voiced by the International Academy of Compounding Pharmacists (IACP) concerning FDA’s July 2014 Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section... Read more
I had an interesting phone call today with a company named ZenDoc — www.getzendoc.com — a software company, headquartered in Dublin, Ireland. The company contacted me to introduce me to their "new" document management software that in their words,... Read more
Today's (4/25/2012) news from In-Pharmatechnologist.com (see full link below) highlights information from FDA's 2011 Warning Letter dataset. The article states that: "In fiscal 2011 the US Food and Drug Administration (FDA) sent biopharma manufacturing-related warning letters to 52 facilities.... Read more
