TY  - BOOK
AU  - Weinberg,Sandy
TI  - Cost-contained regulatory compliance: for the pharmaceutical, biologics, and medical device industries 
SN  - 9780470933503
AV  - HD9994.U52 W45 2011eb
U1  - 615.1068/1 22
PY  - 2011///
CY  - Hoboken, N.J.
PB  - John Wiley & Sons
KW  - United States
KW  - Food and Drug Administration
KW  - Medical instruments and apparatus industry
KW  - Cost control
KW  - Medical instruments and apparatus
KW  - Inspection
KW  - Pharmaceutical industry
KW  - United States. Food and Drug Administration
KW  - Pharmacy
KW  - Business
KW  - Medicine
KW  - MEDICAL
KW  - Drug Guides
KW  - bisacsh
KW  - Pharmacology
KW  - Nursing
KW  - Drug Industry
KW  - economics
KW  - Biotechnology
KW  - Consumer Product Safety
KW  - standards
KW  - Cost Control
KW  - methods
KW  - Equipment and Supplies
KW  - Quality Assurance, Health Care
KW  - Electronic books
N1  - 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; btbi
N2  - 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
UR  - http://dx.doi.org/10.1002/9780470933510
ER  -