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

Shranjeno v:
Bibliografske podrobnosti
Glavni avtor: Weinberg, Sandy, 1950-
Korporativna značnica: ebrary, Inc
Format: Elektronski eKnjiga
Jezik:angleščina
Izdano: Hoboken, N.J. : John Wiley & Sons, c2011.
Teme:
Online dostop:An electronic book accessible through the World Wide Web; click to view
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Kazalo:
  • 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.