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Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries
- Author / Creator
- Available as
- Online
- 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 cos...
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.
Details
- Creator
- Sandy Weinberg
- Format
- Books
- Language
- English
- Publication
-
- Hoboken, N.J. : John Wiley & Sons, [2011]
- ©2011
- Physical Details
-
- 1 online resource (284 pages)
- data file
- ISBNs
- 1283025604, 047093350X, 9781118002278, 9781283025607, 9780470552353, 9780470933503, 9780470933510, 0470933518, 111800227X, 0470552352, 9786613025609
- OCLC
- ocn706476143
- 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
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 -- United States.
Medical Subject Heading
- Biotechnology -- economics -- United States.
Medical Subject Heading
- Consumer Product Safety -- standards -- United States.
Medical Subject Heading
- Cost Control -- methods -- United States.
Medical Subject Heading
- Equipment and Supplies -- economics -- United States.
Medical Subject Heading
- Quality Assurance, Health Care -- economics -- United States.
Medical Subject Heading