Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries /
Sparad:
| Huvudupphov: | |
|---|---|
| Institutionellt upphov: | |
| Materialtyp: | Elektronisk E-bok |
| Språk: | engelska |
| Utgiven: |
Hoboken, N.J. :
John Wiley & Sons,
c2011.
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| Ämnen: | |
| Länkar: | An electronic book accessible through the World Wide Web; click to view |
| Taggar: |
Inga taggar, Lägg till första taggen!
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Innehållsförteckning:
- 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.