Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries /
保存先:
| 第一著者: | |
|---|---|
| 団体著者: | |
| フォーマット: | 電子媒体 eBook |
| 言語: | 英語 |
| 出版事項: |
Hoboken, N.J. :
John Wiley & Sons,
c2011.
|
| 主題: | |
| オンライン･アクセス: | An electronic book accessible through the World Wide Web; click to view |
| タグ: |
タグ追加
タグなし, このレコードへの初めてのタグを付けませんか!
|
目次:
- 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.