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Книга Quality Assurance Gordon Welty

Quality Assurance

Problem Solving and Training Strategies for Success in the Pharmaceutical and Life Science Industries

Автор: Gordon Welty
Език: Английски език
Корици: С твърди корици
Издател: Elsevier Science & Technology
Наличност: Налично при издателя, по поръчка
Изпращаме след 28-34 дни
195.66 € 382.67 лв
Quality assurance is necessary to maintain quality and services in the pharmaceutical and life scien...

Информация за книгата

Автор
Gordon Welty
Език
Английски език
Корици
Книга - С твърди корици
Издадена
2013
страници
374
EAN
9781907568367
ISBN
1907568360
Enbook ID
05027857
Издател
Elsevier Science & Technology
Теглоt
708
Размери
164 x 237 x 27

Пълно описание

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 assurance* An approach grounded in direct experience* Uses diagrams and figures to clarify analytical points

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