Capa in the pharmaceutical and biotech industries: how to implement an effective nine step program
CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program contains the most current information on how to implement, develop, and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop proc...
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Cambridge, UK Waltham, MA
Woodhead Publishing
[2016]
|
| Schriftenreihe: | Woodhead Publishing series in biomedicine
no. 33 |
| Schlagworte: | |
| Online-Zugang: | FAW01 URL des Erstveröffentlichers |
| Zusammenfassung: | CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program contains the most current information on how to implement, develop, and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop process approach for medical devices and pharmaceutical and biologic manufacturers, as well as any anyone who has to maintain a quality system. This book addresses how companies often make the mistake of fixing problems in their processes by revising procedures or, more commonly, by retraining employees that may or may not have caused the problem. This event-focused fix leads to the false assumption that the errors have been eradicated and will be prevented in the future. The reality is that the causes of the failure were never actually determined, therefore the same problem will recur over and over. CAPA is a complete system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause of nonconformities. It is not just a quick-fix, simple approach, it is a process and has to be understood throughout organizations |
| Beschreibung: | Includes bibliographical references and index |
| Beschreibung: | 1 online resource (xiv, 232 pages) illustrations |
| ISBN: | 9781908818379 1908818379 9781907568589 1907568581 |
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Datensatz im Suchindex
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| author | Rodriguez, Jackelyn |
| author_facet | Rodriguez, Jackelyn |
| author_role | aut |
| author_sort | Rodriguez, Jackelyn |
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| building | Verbundindex |
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| dewey-full | 615.190685 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.190685 |
| dewey-search | 615.190685 |
| dewey-sort | 3615.190685 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| format | Electronic eBook |
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| id | DE-604.BV044390214 |
| illustrated | Illustrated |
| indexdate | 2024-07-10T07:51:38Z |
| institution | BVB |
| isbn | 9781908818379 1908818379 9781907568589 1907568581 |
| language | English |
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| physical | 1 online resource (xiv, 232 pages) illustrations |
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| publishDate | 2016 |
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| publishDateSort | 2016 |
| publisher | Woodhead Publishing |
| record_format | marc |
| series2 | Woodhead Publishing series in biomedicine |
| spelling | Rodriguez, Jackelyn Verfasser aut Capa in the pharmaceutical and biotech industries how to implement an effective nine step program Jackelyn Rodriguez Cambridge, UK Waltham, MA Woodhead Publishing [2016] 1 online resource (xiv, 232 pages) illustrations txt rdacontent c rdamedia cr rdacarrier Woodhead Publishing series in biomedicine no. 33 Includes bibliographical references and index CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program contains the most current information on how to implement, develop, and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop process approach for medical devices and pharmaceutical and biologic manufacturers, as well as any anyone who has to maintain a quality system. This book addresses how companies often make the mistake of fixing problems in their processes by revising procedures or, more commonly, by retraining employees that may or may not have caused the problem. This event-focused fix leads to the false assumption that the errors have been eradicated and will be prevented in the future. The reality is that the causes of the failure were never actually determined, therefore the same problem will recur over and over. CAPA is a complete system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause of nonconformities. It is not just a quick-fix, simple approach, it is a process and has to be understood throughout organizations Drug Industry / standards Quality Control Pharmaceutical industry / Quality control fast Pharmaceutical industry Quality control Erscheint auch als Druck-Ausgabe 9781907568589 1907568581 http://www.sciencedirect.com/science/book/9781907568589 Verlag URL des Erstveröffentlichers Volltext |
| spellingShingle | Rodriguez, Jackelyn Capa in the pharmaceutical and biotech industries how to implement an effective nine step program Drug Industry / standards Quality Control Pharmaceutical industry / Quality control fast Pharmaceutical industry Quality control |
| title | Capa in the pharmaceutical and biotech industries how to implement an effective nine step program |
| title_auth | Capa in the pharmaceutical and biotech industries how to implement an effective nine step program |
| title_exact_search | Capa in the pharmaceutical and biotech industries how to implement an effective nine step program |
| title_full | Capa in the pharmaceutical and biotech industries how to implement an effective nine step program Jackelyn Rodriguez |
| title_fullStr | Capa in the pharmaceutical and biotech industries how to implement an effective nine step program Jackelyn Rodriguez |
| title_full_unstemmed | Capa in the pharmaceutical and biotech industries how to implement an effective nine step program Jackelyn Rodriguez |
| title_short | Capa in the pharmaceutical and biotech industries |
| title_sort | capa in the pharmaceutical and biotech industries how to implement an effective nine step program |
| title_sub | how to implement an effective nine step program |
| topic | Drug Industry / standards Quality Control Pharmaceutical industry / Quality control fast Pharmaceutical industry Quality control |
| topic_facet | Drug Industry / standards Quality Control Pharmaceutical industry / Quality control Pharmaceutical industry Quality control |
| url | http://www.sciencedirect.com/science/book/9781907568589 |
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