Quality Assurance

Problem Solving and Training Strategies for Success in the Pharmaceutical and Life Science Industries
Erscheinungsjahr 2013
ISBN: 978-1-907568-36-7
Verlag: Elsevier Science & Technology

Buch, Englisch, 374 Seiten, Format (B × H): 164 mm x 237 mm, Gewicht: 708 g

Reihe: Woodhead Publishing Series in Biomedicine

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.

Autoren/Hrsg.

Welty, Gordon (Adelphi University, USA)

Fachgebiete

• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Sonstige Wirtschaftssektoren & Branchen
• Wirtschaftswissenschaften Betriebswirtschaft Management Qualitätsmanagement, Qualitätssicherung (QS), Total Quality Management (TQM)
• Wirtschaftswissenschaften Betriebswirtschaft Management Compliance
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie

Inhaltsverzeichnis

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.

Über Autor(innen)

Gordon Welty, PhD, 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.