Cost-contained regulatory compliance: for the pharmaceutical, biologics, and medical device industries
Saved in:
| Main Author: | |
|---|---|
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Hoboken, N.J.
John Wiley & Sons
c2011
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| Subjects: | |
| Item Description: | Includes bibliographical references and index |
| Physical Description: | ix, 284 p. |
| ISBN: | 9780470933510 9781118002278 9780470933503 |
Staff View
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| 245 | 1 | 0 | |a Cost-contained regulatory compliance |b for the pharmaceutical, biologics, and medical device industries |c Sandy Weinberg |
| 264 | 1 | |a Hoboken, N.J. |b John Wiley & Sons |c c2011 | |
| 300 | |a ix, 284 p. | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b c |2 rdamedia | ||
| 338 | |b cr |2 rdacarrier | ||
| 500 | |a Includes bibliographical references and index | ||
| 505 | 0 | |a 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 | |
| 610 | 2 | 4 | |a United States |b Food and Drug Administration |
| 650 | 4 | |a Medical instruments and apparatus industry |z United States |x Cost control | |
| 650 | 4 | |a Medical instruments and apparatus |x Inspection |z United States | |
| 650 | 4 | |a Pharmaceutical industry |z United States |x Cost control | |
| 650 | 4 | |a Pharmaceutical industry |x Inspection |z United States | |
| 651 | 4 | |a USA | |
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| author | Weinberg, Sandy 1950- |
| author_facet | Weinberg, Sandy 1950- |
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| 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 |
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| dewey-full | 615.1068/1 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.1068/1 |
| dewey-search | 615.1068/1 |
| dewey-sort | 3615.1068 11 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| format | Electronic eBook |
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| geographic | USA |
| geographic_facet | USA |
| id | DE-604.BV044154765 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T07:45:15Z |
| institution | BVB |
| isbn | 9780470933510 9781118002278 9780470933503 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-029561610 |
| oclc_num | 706476143 |
| open_access_boolean | |
| physical | ix, 284 p. |
| psigel | ZDB-30-PAD ZDB-30-PBE |
| publishDate | 2011 |
| publishDateSearch | 2011 |
| publishDateSort | 2011 |
| publisher | John Wiley & Sons |
| record_format | marc |
| spelling | Weinberg, Sandy 1950- Verfasser aut Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries Sandy Weinberg Hoboken, N.J. John Wiley & Sons c2011 ix, 284 p. txt rdacontent c rdamedia cr rdacarrier 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 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 USA Erscheint auch als Druck-Ausgabe, Hardcover 978-0-470-55235-3 |
| 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 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 |
| title | Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries |
| title_auth | Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries |
| title_exact_search | Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries |
| title_full | Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries Sandy Weinberg |
| title_fullStr | Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries Sandy Weinberg |
| title_full_unstemmed | Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries Sandy Weinberg |
| title_short | Cost-contained regulatory compliance |
| title_sort | cost contained regulatory compliance for the pharmaceutical biologics and medical device industries |
| title_sub | for the pharmaceutical, biologics, and medical device industries |
| topic | 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 |
| topic_facet | 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 USA |
| work_keys_str_mv | AT weinbergsandy costcontainedregulatorycomplianceforthepharmaceuticalbiologicsandmedicaldeviceindustries |