Seven Things to Consider When Selecting a Pharmaceutical Quality Consulting Firm
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
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
Embracing “Quality” Over “Compliance” — A Misguided Approach to Improving FDA-Regulated Quality Outcomes
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
