Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries / / Sandy Weinberg.
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Year of Publication: | 2011 |
Language: | English |
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Physical Description: | ix, 284 p. :; ill. |
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500698933 |
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(MiAaPQ)500698933 (Au-PeEL)EBL698933 (CaPaEBR)ebr10452136 (CaONFJC)MIL302560 (OCoLC)706476143 |
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Weinberg, Sandy, 1950- Cost-contained regulatory compliance [electronic resource] : for the pharmaceutical, biologics, and medical device industries / Sandy Weinberg. Hoboken, N.J. : John Wiley & Sons, c2011. ix, 284 p. : ill. 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. Ann Arbor, MI : ProQuest, 2015. Available via World Wide Web. Access may be limited to ProQuest affiliated libraries. 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. Electronic books. ProQuest (Firm) https://ebookcentral.proquest.com/lib/oeawat/detail.action?docID=698933 Click to View |
language |
English |
format |
Electronic eBook |
author |
Weinberg, Sandy, 1950- |
spellingShingle |
Weinberg, Sandy, 1950- Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries / 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. |
author_facet |
Weinberg, Sandy, 1950- ProQuest (Firm) ProQuest (Firm) |
author_variant |
s w sw |
author2 |
ProQuest (Firm) |
author2_role |
TeilnehmendeR |
author_corporate |
ProQuest (Firm) |
author_sort |
Weinberg, Sandy, 1950- |
title |
Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries / |
title_sub |
for the pharmaceutical, biologics, and medical device industries / |
title_full |
Cost-contained regulatory compliance [electronic resource] : for the pharmaceutical, biologics, and medical device industries / Sandy Weinberg. |
title_fullStr |
Cost-contained regulatory compliance [electronic resource] : for the pharmaceutical, biologics, and medical device industries / Sandy Weinberg. |
title_full_unstemmed |
Cost-contained regulatory compliance [electronic resource] : for the pharmaceutical, biologics, and medical device industries / Sandy Weinberg. |
title_auth |
Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries / |
title_new |
Cost-contained regulatory compliance |
title_sort |
cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries / |
publisher |
John Wiley & Sons, |
publishDate |
2011 |
physical |
ix, 284 p. : ill. |
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. |
isbn |
9780470933503 (electronic bk.) |
callnumber-first |
H - Social Science |
callnumber-subject |
HD - Industries, Land Use, Labor |
callnumber-label |
HD9994 |
callnumber-sort |
HD 49994 U52 W45 42011 |
genre |
Electronic books. |
genre_facet |
Electronic books. |
geographic_facet |
United States United States. |
url |
https://ebookcentral.proquest.com/lib/oeawat/detail.action?docID=698933 |
illustrated |
Illustrated |
dewey-hundreds |
600 - Technology |
dewey-tens |
610 - Medicine & health |
dewey-ones |
615 - Pharmacology & therapeutics |
dewey-full |
615.1068/1 |
dewey-sort |
3615.1068 11 |
dewey-raw |
615.1068/1 |
dewey-search |
615.1068/1 |
oclc_num |
706476143 |
work_keys_str_mv |
AT weinbergsandy costcontainedregulatorycomplianceforthepharmaceuticalbiologicsandmedicaldeviceindustries AT proquestfirm costcontainedregulatorycomplianceforthepharmaceuticalbiologicsandmedicaldeviceindustries |
status_str |
n |
ids_txt_mv |
(MiAaPQ)500698933 (Au-PeEL)EBL698933 (CaPaEBR)ebr10452136 (CaONFJC)MIL302560 (OCoLC)706476143 |
is_hierarchy_title |
Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries / |
author2_original_writing_str_mv |
noLinkedField |
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1792330714427949057 |
fullrecord |
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