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

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...

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Bibliographic Details
Main Author: Weinberg, Sandy, 1950-
Format: Electronic eBook
Language:English
Published: Hoboken, N.J. : John Wiley & Sons, ©2011.
Subjects:
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.
Drug Industry > economics
Biotechnology > economics
Consumer Product Safety > standards
Cost Control > methods
Equipment and Supplies > economics
Quality Assurance, Health Care > economics
United States
Online Access: Full text (Emmanuel users only)
Table of Contents:
  • 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.

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