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CAPA for the FDA-regulated industry / / José Rodríguez Pérez
| CAPA for the FDA-regulated industry / / José Rodríguez Pérez |
| Autore | Rodríguez Pérez José <1961-> |
| Pubbl/distr/stampa | Milwaukee, Wisconsin : , : ASQ Quality Press, , 2010 |
| Descrizione fisica | 1 online resource (166 p.) |
| Disciplina | 615.1068/1 |
| Soggetto topico |
Pharmaceutical industry - Government policy - United States
Food industry and trade - Government policy - United States Total quality management - United States |
| Soggetto genere / forma | Electronic books. |
| ISBN |
600-00-4955-2
1-62198-309-9 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910464171603321 |
Rodríguez Pérez José <1961->
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| Milwaukee, Wisconsin : , : ASQ Quality Press, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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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 |
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Weinberg Sandy <1950->
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| Hoboken, N.J., : John Wiley & Sons, c2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
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 | ||
| ||