Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries /

Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries /

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...

Πλήρης περιγραφή

Λεπτομέρειες βιβλιογραφικής εγγραφής
Κύριος συγγραφέας: Weinberg, Sandy, 1950-
Μορφή: Ηλ. βιβλίο
Γλώσσα:English
Έκδοση: Hoboken, N.J. : John Wiley & Sons, [2011]
Θέματα:
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.
United States. Food and Drug Administration.
Pharmacy.
Business.
Medicine.
MEDICAL > Drug Guides.
MEDICAL > Pharmacology.
MEDICAL > Pharmacy.
MEDICAL > Nursing > Pharmacology.
Drug Industry > economics > United States.
Biotechnology > economics > United States.
Consumer Product Safety > standards > United States.
Cost Control > methods > United States.
Equipment and Supplies > economics > United States.
Quality Assurance, Health Care > economics > United States.
Electronic books.
Διαθέσιμο Online:Full Text via HEAL-Link
LEADER 04873nam a2201021 4500
001 ocn706476143
003 OCoLC
005 20170124072222.7
006 m o d
007 cr cnu---unuuu
008 110309s2011 nju ob 001 0 eng d
010 |z  2010028410 
040 |a N$T  |b eng  |e pn  |c N$T  |d DG1  |d E7B  |d UIU  |d CDX  |d YDXCP  |d EBLCP  |d MHW  |d OCLCQ  |d DEBSZ  |d OCLCQ  |d OCLCA  |d OCLCQ  |d OCLCO  |d IDEBK  |d NLGGC  |d OCLCQ  |d CHVBK  |d OCLCA  |d AU@  |d UKDOC  |d DEBBG  |d OCLCQ  |d D6H  |d AZK  |d GrThAP 
019 |a 711780339  |a 716206102  |a 723440217  |a 741259099  |a 781410801  |a 816649045  |a 961492064  |a 962605728 
020 |a 9780470933503  |q (electronic bk.) 
020 |a 047093350X  |q (electronic bk.) 
020 |a 9780470933510  |q (electronic bk.) 
020 |a 0470933518  |q (electronic bk.) 
020 |a 9781118002278 
020 |a 111800227X 
020 |a 1283025604 
020 |a 9781283025607 
020 |z 9780470552353 
020 |z 0470552352 
024 8 |a 9786613025609 
029 1 |a AU@  |b 000048832470 
029 1 |a AU@  |b 000051561235 
029 1 |a CHBIS  |b 007307088 
029 1 |a CHVBK  |b 182704955 
029 1 |a DEBBG  |b BV041908365 
029 1 |a DEBBG  |b BV043086030 
029 1 |a DEBSZ  |b 372729282 
029 1 |a DEBSZ  |b 421628502 
029 1 |a DEBSZ  |b 430994788 
029 1 |a DEBSZ  |b 449243265 
029 1 |a DKDLA  |b 820120-katalog:000558042 
029 1 |a HEBIS  |b 29982053X 
029 1 |a NZ1  |b 14256077 
029 1 |a DEBBG  |b BV043392896 
035 |a (OCoLC)706476143  |z (OCoLC)711780339  |z (OCoLC)716206102  |z (OCoLC)723440217  |z (OCoLC)741259099  |z (OCoLC)781410801  |z (OCoLC)816649045  |z (OCoLC)961492064  |z (OCoLC)962605728 
037 |a 10.1002/9780470933510  |b Wiley InterScience  |n http://www3.interscience.wiley.com 
043 |a n-us--- 
050 4 |a HD9994.U52  |b W45 2011eb 
060 4 |a QV 736 
072 7 |a MED  |x 023000  |2 bisacsh 
072 7 |a MED  |x 071000  |2 bisacsh 
072 7 |a MED  |x 072000  |2 bisacsh 
072 7 |a MED  |x 058170  |2 bisacsh 
072 7 |a MMG  |2 bicssc 
082 0 4 |a 615.1068/1  |2 22 
049 |a MAIN 
100 1 |a Weinberg, Sandy,  |d 1950- 
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 [2011] 
264 4 |c ©2011 
300 |a 1 online resource (284 pages) 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
347 |a data file  |2 rda 
380 |a Bibliography 
504 |a Includes bibliographical references (pages 273-277) 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. 
520 |a 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. 
588 0 |a Print version record. 
610 1 0 |a United States.  |b Food and Drug Administration. 
650 0 |a Medical instruments and apparatus industry  |z United States  |x Cost control. 
650 0 |a Medical instruments and apparatus  |x Inspection  |z United States. 
650 0 |a Pharmaceutical industry  |z United States  |x Cost control. 
650 0 |a Pharmaceutical industry  |x Inspection  |z United States. 
650 4 |a United States. Food and Drug Administration. 
650 4 |a Pharmacy. 
650 4 |a Business. 
650 4 |a Medicine. 
650 7 |a MEDICAL  |x Drug Guides.  |2 bisacsh 
650 7 |a MEDICAL  |x Pharmacology.  |2 bisacsh 
650 7 |a MEDICAL  |x Pharmacy.  |2 bisacsh 
650 7 |a MEDICAL  |x Nursing  |x Pharmacology.  |2 bisacsh 
650 2 |a Drug Industry  |x economics  |z United States. 
650 2 |a Biotechnology  |x economics  |z United States. 
650 2 |a Consumer Product Safety  |x standards  |z United States. 
650 2 |a Cost Control  |x methods  |z United States. 
650 2 |a Equipment and Supplies  |x economics  |z United States. 
650 2 |a Quality Assurance, Health Care  |x economics  |z United States. 
655 4 |a Electronic books. 
776 0 8 |i Print version:  |a Weinberg, Sandy, 1950-  |t Cost-contained regulatory compliance.  |d Hoboken, N.J. : John Wiley & Sons, ©2011  |z 9780470552353  |w (DLC) 2010028410  |w (OCoLC)646388488 
856 4 0 |u https://doi.org/10.1002/9780470933510  |z Full Text via HEAL-Link 
994 |a 92  |b DG1 

Παρόμοια τεκμήρια