Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries /
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| 主要作者: | |
|---|---|
| 企業作者: | |
| 格式: | 電子 電子書 |
| 語言: | 英语 |
| 出版: |
Hoboken, N.J. :
John Wiley & Sons,
c2011.
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| 主題: | |
| 在線閱讀: | An electronic book accessible through the World Wide Web; click to view |
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書本目錄:
- 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.