Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries /
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...
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Full text (MCPHS users only) |
|---|---|
| Main Author: | |
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Hoboken, N.J. :
John Wiley & Sons,
2011
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| Subjects: | |
| Local Note: | ProQuest Ebook Central |
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| 100 | 1 | |a Weinberg, Sandy, |d 1950- |1 https://id.oclc.org/worldcat/entity/E39PCjt9pDRJCKVX8mwqYmgTh3 | |
| 245 | 1 | 0 | |a Cost-contained regulatory compliance : |b for the pharmaceutical, biologics, and medical device industries / |c Sandy Weinberg. |
| 260 | |a Hoboken, N.J. : |b John Wiley & Sons, |c ©2011. | ||
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| 504 | |a Includes bibliographical references (pages 273-277) and index. | ||
| 505 | 0 | |a 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. | |
| 520 | |a 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. | ||
| 546 | |a English. | ||
| 588 | 0 | |a Print version record. | |
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| 650 | 0 | |a Medical instruments and apparatus |x Inspection |z United States. | |
| 650 | 0 | |a Pharmaceutical industry |z United States |x Cost control. | |
| 650 | 0 | |a Pharmaceutical industry |x Inspection |z United States. | |
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| 650 | 2 | 2 | |a Biotechnology |x economics |
| 650 | 2 | 2 | |a Consumer Product Safety |x standards |
| 650 | 2 | 2 | |a Cost Control |x methods |
| 650 | 2 | 2 | |a Equipment and Supplies |x economics |
| 650 | 2 | 2 | |a Quality Assurance, Health Care |x economics |
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