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Informationen zum Autor 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. Klappentext 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. Zusammenfassung 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. 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 recordkeeping; Formative evaluation; Final implementation. ...
List 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.
