Handling Non-Compliance Situations

Nigel J Smart PhD is the President of SMART Pharmaceutical Consulting, a West Chester, Pennsylvania, USA Life Sciences consulting firm.

He is a serial entrepreneur with decades of experience in the biotechnology/pharmaceutical industry; many of those based in North America in both corporate and consulting capacities. He consults on a variety of Life Sciences topics with particular interest in Lean and Performance strategies in Bioprocess Development/Manufacturing, in addition to the application of Quality Compliance principles to modern processes. In relation to these topics, he is particularly focused on digital applications associated with generating what he terms Powerhouse High Performance outcomes. In relation to Quality Compliance, Nigel has acted as an expert consultant for the FDA on cGMP and Data Integrity issues and assists both domestic and foreign companies with sustainable Quality Compliance strategies. As part of his government service, Nigel has assisted both the Biological Advanced Research & Development Authority (BARDA), and the Department of Defense in the relation to the production of anti-terrorist countermeasures. He has a special interest in the application of LEAN Process Excellence principles to Bioprocess Manufacturing systems and is the author of a book dedicated to this topic entitled “Lean Biomanufacturing” Oxford Health Publishers.