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

By: Weinberg, Sandy, 1950-.
Material type: materialTypeLabelBookPublisher: Hoboken, N.J. : John Wiley & Sons, ©2011Description: 1 online resource (284 pages).Content type: text Media type: computer Carrier type: online resourceISBN: 9780470933503; 047093350X; 9780470933510; 0470933518; 9781118002278; 111800227X; 1283025604; 9781283025607.Subject(s): 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 | United States. Food and Drug Administration | Pharmacy | Business | Medicine | MEDICAL -- Drug Guides | MEDICAL -- Pharmacology | MEDICAL -- Pharmacy | MEDICAL -- Nursing -- Pharmacology | 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 StatesGenre/Form: Electronic books.Additional physical formats: Print version:: Cost-contained regulatory compliance.DDC classification: 615.1068/1 Online resources: Wiley Online Library
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.
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.
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Includes bibliographical references (pages 273-277) and index.

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.

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.

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