Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries /
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| Главный автор: | |
|---|---|
| Соавтор: | |
| Формат: | Электронный ресурс eКнига |
| Язык: | английский |
| Опубликовано: |
Hoboken, N.J. :
John Wiley & Sons,
c2011.
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| Предметы: | |
| Online-ссылка: | An electronic book accessible through the World Wide Web; click to view |
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Оглавление:
- 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.