In our day jobs we help companies comply with FDA regulations. Frequently, however, we find that the underlying cause of poor compliance performance is a lack of understanding of the basic technology of their manufacturing process. But beneath even that often lies a more fundamental challenge that many organizations struggle with: how to help technical personnel to improve people management skills. In this blog we will touch on some of the non-technical aspects of compliance management.
How do we know what Quality means in our business? As quality consultants for the pharmaceutical and medical device industries, that’s a question we hear frequently. Maybe not in so many words; but many times the question boils down to that.