Quality Assurance

Gordon Welty is currently Lecturer in Social Science at Adelphi University, USA . He has extensive professional experience in program development and the management of organizational change. He gained his doctorate from the University of Pittsburgh, USA , and was named Professor Emeritus at Wright State University in 1998. Welty was recruited to develop, rollout, and manage the GMP Trainthe-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.

Part 1 A systematic approach to problem solving: Framework for continuous improvement; Investigations, root cause analyses and CAPAs; The role of critical review in the revision of procedures; Working with standard operating procedures (SOPs). Part 2 Designing and developing training materials: The design phase of the program improvement model; Content development: A new employee orientation program; Content development: A continuing cGMP training program; Content development: Qualification of employees. Part 3 Using the training materials: Assessing trainee proficiency; Pilot implementation; Training record- keeping; Formative evaluation; Final implementation.