Synopses & Reviews
Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Gordon Welty demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This book explains how a problem in regulated industry is identified, reviews the decision making steps involved in remedying the problem and the staff training requirements of revised procedures and offers a proposed training program.
About the Author
Gordon Welty, Ph.D. is currently Lecturer in Social Science at Adelphi University, New York. He has extensive professional experience in program development and the management of organizational change.
Table of Contents
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