TY  - BOOK
AU  - Weinberg,Sandy
ED  - ebrary, Inc.
TI  - Cost-contained regulatory compliance: for the pharmaceutical, biologics, and medical device industries 
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  - Electronic books
KW  - local
N1  - Includes bibliographical references 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; Electronic reproduction; Palo Alto, Calif.; ebrary; 2011; Available via World Wide Web; Access may be limited to ebrary affiliated libraries
UR  - http://site.ebrary.com/lib/welingkar/Doc?id=10452136
ER  -