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

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Electronic resources

Subject: United States. Food and Drug Administration.
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 > United States.
Biotechnology > economics > United States.
Consumer Product Safety > standards > United States.
Cost Control > methods > United States.
Equipment and Supplies > economics > United States.
Quality Assurance, Health Care > economics > United States.
Genre: Electronic books.
Electronic book.

Record details

  • ISBN: 9780470933503
  • ISBN: 047093350X
  • ISBN: 9780470933510
  • ISBN: 0470933518
  • ISBN: 9781118002278
  • ISBN: 111800227X
  • ISBN: 1283025604
  • ISBN: 9781283025607
  • Physical Description: 1 online resource (284 pages)
  • Publisher: Hoboken, N.J. : John Wiley & Sons, ©2011.

Content descriptions

Bibliography, etc. Note: Includes bibliographical references (pages 273-277) and index.
Formatted Contents Note: 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.
Summary: 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 through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.
Source of Description Note: Print version record.
◄ Search Results Showing Item 10 of 15

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