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Author Weinberg, Sandy, 1950-

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

Imprint Hoboken, N.J. : John Wiley & Sons, 2011.


Location Call No. OPAC Message Status
 Axe EBSCO Clinical Nursing E-Book  Electronic Book    ---  Available
Description 1 online resource (284 pages)
text txt rdacontent
computer c rdamedia
online resource cr rdacarrier
Physical Medium polychrome. rdacc
Description data file
Bibliography Includes bibliographical references (pages 273-277) and index.
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.
Note Print version record.
Language English.
Subject United States. Food and Drug Administration.
United States. Food and Drug Administration. (OCoLC)fst00549734
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
MEDICAL -- Drug Guides.
MEDICAL -- Pharmacology.
MEDICAL -- Pharmacy.
MEDICAL -- Nursing -- Pharmacology.
Medical instruments and apparatus -- Inspection. (OCoLC)fst01014211
United States. (OCoLC)fst01204155
Genre/Form Electronic books.
Electronic books.
Electronic books.
Other Form: Print version: Weinberg, Sandy, 1950- Cost-contained regulatory compliance. Hoboken, N.J. : John Wiley & Sons, 2011 9780470552353 (DLC) 2010028410 (OCoLC)646388488
ISBN 9780470933503 (electronic bk.)
047093350X (electronic bk.)
9780470933510 (electronic bk.)
0470933518 (electronic bk.)
Standard No. 9780470552353
AU@ 000048832470
AU@ 000051561235
CHBIS 007307088
CHNEW 000937450
CHVBK 480177570
DEBBG BV041908365
DEBBG BV043086030
DEBBG BV043392896
DEBBG BV044154765
DEBSZ 372729282
DEBSZ 383112176
DEBSZ 421628502
DEBSZ 430994788
DEBSZ 449243265
DEBSZ 449838110
DEBSZ 48500027X
GBVCP 681304448
GWDNB 106384083X
GWDNB 1064486304
HEBIS 29982053X
NZ1 14256077

Available items only