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

This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access...

Πλήρης περιγραφή

Λεπτομέρειες βιβλιογραφικής εγγραφής
Κύριος συγγραφέας: Weinberg, Sandy, 1950-
Μορφή: Ηλ. βιβλίο
Γλώσσα:English
Έκδοση: Hoboken, N.J. : John Wiley & Sons, [2011]
Θέματα:
Διαθέσιμο Online:Full Text via HEAL-Link
Πίνακας περιεχομένων:
  • 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.