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
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
