Quality Assurance: Problem Solving and Training Strategies for Success in the Pharmaceutical and Life Science Industries
Author:   Gordon Welty (Adelphi University, USA)
Publisher:   Elsevier Science & Technology
Volume:   55
ISBN:  

9781907568367


Pages:   374
Publication Date:   30 June 2013
Format:   Hardback
Availability:   Manufactured on demand   Availability explained
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Quality Assurance: Problem Solving and Training Strategies for Success in the Pharmaceutical and Life Science Industries


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Author:   Gordon Welty (Adelphi University, USA)
Publisher:   Elsevier Science & Technology
Imprint:   Woodhead Publishing Ltd
Volume:   55
Dimensions:   Width: 15.60cm , Height: 2.20cm , Length: 23.40cm
Weight:   0.720kg
ISBN:  

9781907568367


ISBN 10:   1907568360
Pages:   374
Publication Date:   30 June 2013
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   Manufactured on demand   Availability explained
We will order this item for you from a manufactured on demand supplier.

Table of Contents

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.

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Author Information

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.

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