Quality Assurance: Problem Solving and Training Strategies for Success in the Pharmaceutical and Life Science Industries (Woodhead Publishing Series in Biomedicine) - Hardcover

Welty, G

Hardcover

ISBN 10: 1907568360 ISBN 13: 9781907568367

Publisher: Woodhead Publishing, 2013

Synopsis

Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Quality assurance demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This title is divided into three parts; the first part discusses the process by which a problem in regulated industry is identified, for example a manufacturing deviation that leads to an adulterated drug product, and reviews the decision-making steps involved in remedying the problem. The second part delves into the staff training requirements of procedures that are thereby revised. The third part expands on this discussion by considering piloting the proposed training module, preparing assessments of trainee proficiency, evaluating the training module, including integrating rigorous evaluative designs with formative program improvement, and documenting the entire effort.

• Presents a comprehensive view of the field of quality assurance
• An approach grounded in direct experience
• Uses diagrams and figures to clarify analytical points

About this title

About the Author

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.

Edition details

• Publisher: Woodhead Publishing
• Publication date: 2013
• Language: English
• ISBN 10: 1907568360
• ISBN 13: 9781907568367
• Binding: Hardcover
• Edition number: 1
• Number of pages: 374