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

Kaydedildi:
Detaylı Bibliyografya
Yazar: Weinberg, Sandy, 1950-
Müşterek Yazar: ebrary, Inc
Materyal Türü: Elektronik Ekitap
Dil:İngilizce
Baskı/Yayın Bilgisi: Hoboken, N.J. : John Wiley & Sons, c2011.
Konular:
Online Erişim:An electronic book accessible through the World Wide Web; click to view
Etiketler: Etiketle
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İçindekiler:
  • 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.