Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries /
Bewaard in:
| Hoofdauteur: | |
|---|---|
| Coauteur: | |
| Formaat: | Elektronisch E-boek |
| Taal: | Engels |
| Gepubliceerd in: |
Hoboken, N.J. :
John Wiley & Sons,
c2011.
|
| Onderwerpen: | |
| Online toegang: | An electronic book accessible through the World Wide Web; click to view |
| Tags: |
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Inhoudsopgave:
- 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.