Image de couverture de livre

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

Enregistré dans:
Détails bibliographiques
Auteur principal: Weinberg, Sandy, 1950-
Collectivité auteur: ebrary, Inc
Format: Électronique eBook
Langue:anglais
Publié: Hoboken, N.J. : John Wiley & Sons, c2011.
Sujets:
United States. > Food and Drug Administration.
Medical instruments and apparatus industry > United States > Cost control.
Medical instruments and apparatus > Inspection > United States.
Pharmaceutical industry > United States > Cost control.
Pharmaceutical industry > Inspection > United States.
Electronic books.
Accès en ligne:An electronic book accessible through the World Wide Web; click to view
Tags: Ajouter un tag
Pas de tags, Soyez le premier à ajouter un tag!
Table des matières:
  • 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.

Documents similaires