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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...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken, N.J. :
John Wiley & Sons,
©2011.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- 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.