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.
In FDA regulated industries we have to comply with GMPs. It’s a federal law. But we also have to make a profit. It’s the law of the invisible hand from Adam Smith. Our question is, How can we do both?