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Biblioteca

MARC Lista (tabellare)
Cost-contained regulatory compliance [[electronic resource] ] : for the pharmaceutical, biologics, and medical device industries / / Sandy Weinberg
Cost-contained regulatory compliance [[electronic resource] ] : for the pharmaceutical, biologics, and medical device industries / / Sandy Weinberg
Autore Weinberg Sandy <1950->
Pubbl/distr/stampa Hoboken, N.J., : John Wiley & Sons, c2011
Descrizione fisica 1 online resource (296 p.)
Disciplina 615.1068/1
Soggetto topico 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
ISBN 1-118-00227-X
1-283-02560-4
9786613025609
0-470-93350-X
0-470-93351-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto 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.
Record Nr. UNINA-9910133581103321
Weinberg Sandy <1950->  
Hoboken, N.J., : John Wiley & Sons, c2011
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries / / Sandy Weinberg
Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries / / Sandy Weinberg
Autore Weinberg Sandy <1950->
Edizione [1st ed.]
Pubbl/distr/stampa Hoboken, N.J., : John Wiley & Sons, c2011
Descrizione fisica 1 online resource (296 p.)
Disciplina 615.1068/1
Soggetto topico 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
ISBN 1-118-00227-X
1-283-02560-4
9786613025609
0-470-93350-X
0-470-93351-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto 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.
Record Nr. UNINA-9910827252303321
Weinberg Sandy <1950->  
Hoboken, N.J., : John Wiley & Sons, c2011
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Medical devices [[electronic resource] ] : shortcomings in FDA's premarket review, postmarket surveillance, and inspections of device manufacturing establishments : testimony before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives / / statement of Marcia Crosse
Medical devices [[electronic resource] ] : shortcomings in FDA's premarket review, postmarket surveillance, and inspections of device manufacturing establishments : testimony before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives / / statement of Marcia Crosse
Autore Crosse Marcia
Pubbl/distr/stampa [Washington, D.C.] : , : U.S. Govt. Accountability Office, , [2009]
Descrizione fisica 1 online resource (18 pages) : illustrations
Collana Testimony
Soggetto topico Medical instruments and apparatus industry - United States
Medical instruments and apparatus - Inspection - United States
Risk assessment - Government policy - United States
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Altri titoli varianti Medical devices
Record Nr. UNINA-9910699069003321
Crosse Marcia  
[Washington, D.C.] : , : U.S. Govt. Accountability Office, , [2009]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Requests for inspection by an accredited person under the Inspection by Accredited Persons Program authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002 [[electronic resource]]
Requests for inspection by an accredited person under the Inspection by Accredited Persons Program authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002 [[electronic resource]]
Pubbl/distr/stampa [Rockville, MD] : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : , : Center for Biologics Evaluation and Research, , [2005]
Descrizione fisica 11 pages : digital, PDF file
Soggetto topico Medical instruments and apparatus - Inspection - United States
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Altri titoli varianti Guidance for industry, FDA staff, and FDA-accredited third parties
Record Nr. UNINA-9910698843303321
[Rockville, MD] : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : , : Center for Biologics Evaluation and Research, , [2005]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui