Cost-contained regulatory compliance: for the pharmaceutical, biologics, and medical device industries
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Hoboken, N.J.
John Wiley & Sons
©2011
|
| Schlagworte: | |
| Online-Zugang: | FAW01 FAW02 Volltext |
| Beschreibung: | Includes bibliographical references (pages 273-277) and index Controlling regulatory costs -- Clear operation definitions of requirements -- Pre-regulatory audits -- Quality by design -- Outsourcing -- Electronic submissions -- Emea/fda coordination -- Managing FDA inspections -- Risk assessment -- Cases -- Cost containment analysis -- Managing regulation in times of chaos -- International regulation -- Cost contained regulatory compliance This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries |
| Beschreibung: | 1 Online-Ressource (284 pages) |
| ISBN: | 0470552352 047093350X 0470933518 111800227X 9780470552353 9780470933503 9780470933510 9781118002278 |
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| 245 | 1 | 0 | |a Cost-contained regulatory compliance |b for the pharmaceutical, biologics, and medical device industries |c Sandy Weinberg |
| 264 | 1 | |a Hoboken, N.J. |b John Wiley & Sons |c ©2011 | |
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| 500 | |a Includes bibliographical references (pages 273-277) and index | ||
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Datensatz im Suchindex
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| any_adam_object | |
| author | Weinberg, Sandy |
| author_facet | Weinberg, Sandy |
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| author_sort | Weinberg, Sandy |
| author_variant | s w sw |
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| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.1068/1 |
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| geographic | USA |
| geographic_facet | USA |
| id | DE-604.BV043086030 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T07:16:59Z |
| institution | BVB |
| isbn | 0470552352 047093350X 0470933518 111800227X 9780470552353 9780470933503 9780470933510 9781118002278 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-028510222 |
| oclc_num | 706476143 |
| open_access_boolean | |
| owner | DE-1046 DE-1047 |
| owner_facet | DE-1046 DE-1047 |
| physical | 1 Online-Ressource (284 pages) |
| psigel | ZDB-4-EBA ZDB-4-EBA FAW_PDA_EBA |
| publishDate | 2011 |
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| publishDateSort | 2011 |
| publisher | John Wiley & Sons |
| record_format | marc |
| spelling | Weinberg, Sandy Verfasser aut Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries Sandy Weinberg Hoboken, N.J. John Wiley & Sons ©2011 1 Online-Ressource (284 pages) txt rdacontent c rdamedia cr rdacarrier Includes bibliographical references (pages 273-277) and index Controlling regulatory costs -- Clear operation definitions of requirements -- Pre-regulatory audits -- Quality by design -- Outsourcing -- Electronic submissions -- Emea/fda coordination -- Managing FDA inspections -- Risk assessment -- Cases -- Cost containment analysis -- Managing regulation in times of chaos -- International regulation -- Cost contained regulatory compliance This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries United States Food and Drug Administration United States. Food and Drug Administration Pharmacy Business Medicine MEDICAL / Drug Guides bisacsh MEDICAL / Pharmacology bisacsh MEDICAL / Pharmacy bisacsh MEDICAL / Nursing / Pharmacology bisacsh Drug Industry / economics / United States Biotechnology / economics / United States Consumer Product Safety / standards / United States Cost Control / methods / United States Equipment and Supplies / economics / United States Quality Assurance, Health Care / economics / United States Medizin Wirtschaft Medical instruments and apparatus industry United States Cost control Medical instruments and apparatus Inspection United States Pharmaceutical industry United States Cost control Pharmaceutical industry Inspection United States USA http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=357501 Aggregator Volltext |
| spellingShingle | Weinberg, Sandy Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries United States Food and Drug Administration United States. Food and Drug Administration Pharmacy Business Medicine MEDICAL / Drug Guides bisacsh MEDICAL / Pharmacology bisacsh MEDICAL / Pharmacy bisacsh MEDICAL / Nursing / Pharmacology bisacsh Drug Industry / economics / United States Biotechnology / economics / United States Consumer Product Safety / standards / United States Cost Control / methods / United States Equipment and Supplies / economics / United States Quality Assurance, Health Care / economics / United States Medizin Wirtschaft Medical instruments and apparatus industry United States Cost control Medical instruments and apparatus Inspection United States Pharmaceutical industry United States Cost control Pharmaceutical industry Inspection United States |
| title | Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries |
| title_auth | Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries |
| title_exact_search | Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries |
| title_full | Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries Sandy Weinberg |
| title_fullStr | Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries Sandy Weinberg |
| title_full_unstemmed | Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries Sandy Weinberg |
| title_short | Cost-contained regulatory compliance |
| title_sort | cost contained regulatory compliance for the pharmaceutical biologics and medical device industries |
| title_sub | for the pharmaceutical, biologics, and medical device industries |
| topic | United States Food and Drug Administration United States. Food and Drug Administration Pharmacy Business Medicine MEDICAL / Drug Guides bisacsh MEDICAL / Pharmacology bisacsh MEDICAL / Pharmacy bisacsh MEDICAL / Nursing / Pharmacology bisacsh Drug Industry / economics / United States Biotechnology / economics / United States Consumer Product Safety / standards / United States Cost Control / methods / United States Equipment and Supplies / economics / United States Quality Assurance, Health Care / economics / United States Medizin Wirtschaft Medical instruments and apparatus industry United States Cost control Medical instruments and apparatus Inspection United States Pharmaceutical industry United States Cost control Pharmaceutical industry Inspection United States |
| topic_facet | United States Food and Drug Administration United States. Food and Drug Administration Pharmacy Business Medicine MEDICAL / Drug Guides MEDICAL / Pharmacology MEDICAL / Pharmacy MEDICAL / Nursing / Pharmacology Drug Industry / economics / United States Biotechnology / economics / United States Consumer Product Safety / standards / United States Cost Control / methods / United States Equipment and Supplies / economics / United States Quality Assurance, Health Care / economics / United States Medizin Wirtschaft Medical instruments and apparatus industry United States Cost control Medical instruments and apparatus Inspection United States Pharmaceutical industry United States Cost control Pharmaceutical industry Inspection United States USA |
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