Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries /
Gorde:
Egile nagusia: | |
---|---|
Erakunde egilea: | |
Formatua: | Baliabide elektronikoa eBook |
Hizkuntza: | ingelesa |
Argitaratua: |
Hoboken, N.J. :
John Wiley & Sons,
c2011.
|
Gaiak: | |
Sarrera elektronikoa: | An electronic book accessible through the World Wide Web; click to view |
Etiketak: |
Etiketa erantsi
Etiketarik gabe, Izan zaitez lehena erregistro honi etiketa jartzen!
|
Aurkibidea:
- 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.