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Weinberg, Sandy, 1950-

Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries / Sandy Weinberg. - Hoboken, N.J. : John Wiley & Sons, ©2011. - 1 online resource (284 pages)

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.

9780470933503 047093350X 9780470933510 0470933518 9781118002278 111800227X 1283025604 9781283025607


10.1002/9780470933510 Wiley InterScience http://www3.interscience.wiley.com

United States. Food and Drug Administration.

Medical instruments and apparatus industry--Cost control.--United States
Medical instruments and apparatus--Inspection--United States.
Pharmaceutical industry--Cost control.--United States
Pharmaceutical industry--Inspection--United States.
United States. Food and Drug Administration.
MEDICAL--Drug Guides.
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.

Electronic books.

HD9994.U52 / W45 2011eb


QV 736

Khulna University of Engineering & Technology

Funded by: HEQEP, UGC, Bangladesh