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Book Cover
Author Welty, Gordon, author

Title Quality assurance : problem solving and training strategies for success in the pharmaceutical and life science industries / Gordon Welty
Published Oxford : Woodhead Publishing, 2013


Description 1 online resource (xxv, 347 pages) : illustrations
Series Woodhead publishing series in biomedicine, 2050-0289 ; number 55
Woodhead Publishing series in biomedicine ; no. 55.
Contents Part I.A systematic approach to problem solving -- part II. Designing and developing training materials -- part III. Using the training materials
Summary 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 assuranceAn approach grounded in direct experienceUses diagrams and figures to clarify analytical points
Bibliography Includes bibliographical references and index
Notes Print version record
Subject Pharmacy management -- Quality control
Pharmaceutical industry -- Quality control
Life sciences -- Quality control
Quality control.
Drug Industry -- standards
Biological Science Disciplines -- education
Biological Science Disciplines -- standards
Drug Industry -- education
Quality Control
quality control.
MEDICAL -- Pharmacology.
Quality control
Pharmaceutical industry -- Quality control
United States
Form Electronic book
LC no. 2013931127
ISBN 9781908818621