Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries /

Gorde:
Xehetasun bibliografikoak
Egile nagusia: Weinberg, Sandy, 1950-
Erakunde egilea: ebrary, Inc
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.