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

Wedi'i Gadw mewn:
Manylion Llyfryddiaeth
Prif Awdur: Weinberg, Sandy, 1950-
Awdur Corfforaethol: ebrary, Inc
Fformat: Electronig eLyfr
Iaith:Saesneg
Cyhoeddwyd: Hoboken, N.J. : John Wiley & Sons, c2011.
Pynciau:
Mynediad Ar-lein:An electronic book accessible through the World Wide Web; click to view
Tagiau: Ychwanegu Tag
Dim Tagiau, Byddwch y cyntaf i dagio'r cofnod hwn!
Tabl Cynhwysion:
  • 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.