Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries /
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| Autor principal: | |
|---|---|
| Autor Corporativo: | |
| Formato: | Recurso Eletrônico livro eletrônico |
| Idioma: | inglês |
| Publicado em: |
Hoboken, N.J. :
John Wiley & Sons,
c2011.
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| Assuntos: | |
| Acesso em linha: | An electronic book accessible through the World Wide Web; click to view |
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Sumário:
- 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.