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Quality assurance : problem solving and training strategies for success in the pharmaceutical and life science industries /
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...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Oxford :
Woodhead Publishing,
2013.
|
| Colección: | Woodhead Publishing series in biomedicine ;
no. 55. |
| Temas: | |
| Acceso en línea: | Texto completo (Requiere registro previo con correo institucional) |
MARC
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| 100 | 1 | |a Welty, Gordon, |e author. | |
| 245 | 1 | 0 | |a Quality assurance : |b problem solving and training strategies for success in the pharmaceutical and life science industries / |c Gordon Welty. |
| 264 | 1 | |a Oxford : |b Woodhead Publishing, |c 2013. | |
| 300 | |a 1 online resource (xxv, 347 pages) : |b illustrations | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 490 | 1 | |a Woodhead publishing series in biomedicine, |x 2050-0289 ; |v number 55 | |
| 504 | |a Includes bibliographical references and index. | ||
| 588 | 0 | |a Print version record. | |
| 520 | |a 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. | ||
| 505 | 0 | |a Part I.A systematic approach to problem solving -- part II. Designing and developing training materials -- part III. Using the training materials. | |
| 590 | |a O'Reilly |b O'Reilly Online Learning: Academic/Public Library Edition | ||
| 650 | 0 | |a Pharmacy management |x Quality control. | |
| 650 | 0 | |a Pharmaceutical industry |x Quality control. | |
| 650 | 0 | |a Life sciences |x Quality control. | |
| 650 | 0 | |a Quality control. | |
| 650 | 1 | 2 | |a Drug Industry |x standards |
| 650 | 2 | 2 | |a Biological Science Disciplines |x education |
| 650 | 2 | 2 | |a Biological Science Disciplines |x standards |
| 650 | 2 | 2 | |a Drug Industry |x education |
| 650 | 2 | 2 | |a Quality Control |
| 651 | 2 | |a United States | |
| 650 | 6 | |a Pharmacies |x Gestion |x Qualité |x Contrôle. | |
| 650 | 6 | |a Industrie pharmaceutique |x Qualité |x Contrôle. | |
| 650 | 6 | |a Sciences de la vie |x Qualité |x Contrôle. | |
| 650 | 6 | |a Qualité |x Contrôle. | |
| 650 | 7 | |a quality control. |2 aat | |
| 650 | 7 | |a MEDICAL |x Pharmacology. |2 bisacsh | |
| 650 | 7 | |a Quality control |2 fast | |
| 650 | 7 | |a Pharmaceutical industry |x Quality control |2 fast | |
| 655 | 4 | |a Internet Resources. | |
| 776 | 0 | 8 | |i Print version: |a Welty, Gordon. |t Quality assurance |z 9781907568367 |w (OCoLC)858915073 |
| 830 | 0 | |a Woodhead Publishing series in biomedicine ; |v no. 55. | |
| 856 | 4 | 0 | |u https://learning.oreilly.com/library/view/~/9781907568367/?ar |z Texto completo (Requiere registro previo con correo institucional) |
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