About the content
Five groups of stakeholders in the sphere of FDA-regulated industry are identified: operational employees, quality unit auditors, regulatory investigators, health care providers, and patients.
The kinds of observations that tend to be associated with each of these stakeholders initiate an investigation and revising process that varies in emphasis but that has an underlying logic. An observation is typically escalated, triaged, and can become the basis of an investigation and root cause analysis.
This article considers occasions that lead to the continuous improvement of GMP processes (Good Manufacturing Practices) and the revision of SOPs (Standard Operation Procedure).
About the author
Gordon Welty, Ph.D., has extensive professional experience in program development and the management of organizational change. His doctorate is from the University of Pittsburgh, USA. He was named Professor Emeritus at Wright State University in 1998. He is currently Lecturer in Social Science at Adelphi University. Welty was recruited to develop, rollout, and manage the GMP Train-the-Trainer program as corrective action/preventive action (CAPA) for Schering-Plough’s consent decree in 2003. His writings have appeared in such scholarly publications as the Academy of Management Journal, International Sociological Review, Journal of GXP Compliance, and Metroeconomica, as well as a number of anthologies. He was the recipient of the Institute of Validation Technology’s “Author of the Year” Award in 2008, 2009 and 2010.