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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spelling 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
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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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