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[null,"1.","Record Nr.",null,"UNINA9910131095003321"]
[null,null,"Autore",null,"Cusson Maurice"]
[null,null,"Titolo",null,"Le modèle québécois / / Maurice Cusson"]
[null,null,"Pubbl/distr/stampa",null,"Chicoutimi : , : J.-M. Tremblay, , 2006"]
[null,null,"ISBN",null,"1-4123-5323-8"]
[null,null,"Descrizione fisica",null,"1 online resource"]
[null,null,"Collana",null,"Classiques des sciences sociales"]
[null,null,"Disciplina",null,"364"]
[null,null,"Soggetti",null,"Criminology"]
[null,null,"Lingua di pubblicazione",null,"Francese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,"Nota di contenuto",null,"Introduction  -- Origines  -- Un sociologue parmi les psychologues -- Des auspices favorables  -- Tâtonnements et tiraillements  -- Radicaux et réformistes -- La recherche et la pratique  -- Le \"modèle\"  -- Une connaissance rigoureuse et intégrée du phénomène criminel -- Le pragmatisme -- L'analyse objective et systématique de questions criminelles particulières  -- Conclusion."]
[null,"2.","Record Nr.",null,"UNINA9911020121703321"]
[null,null,"Autore",null,"Bliesner David M"]
[null,null,"Titolo",null,"Establishing a CGMP laboratory audit system : a practical guide / / David M. Bliesner"]
[null,null,"Pubbl/distr/stampa",null,"Hoboken, N.J., : Wiley-Interscience, c2006"]
[null,null,"ISBN",null,"9786610448081"]
[{"$nulls":4},"9781280448089"]
[{"$nulls":4},"1280448083"]
[{"$nulls":4},"9780470239384"]
[{"$nulls":4},"0470239387"]
[{"$nulls":4},"9780471784784"]
[{"$nulls":4},"0471784788"]
[{"$nulls":4},"9780471784777"]
[{"$nulls":4},"047178477X"]
[null,null,"Descrizione fisica",null,"1 online resource (295 p.)"]
[null,null,"Disciplina",null,"343.7307/86151"]
[null,null,"Soggetti",null,"Pharmaceutical industry - United States"]
[{"$nulls":4},"Drugs - Law and legislation - United States"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Note generali","Description based upon print version of record."]
[null,null,null,"Nota di bibliografia","Includes bibliographical references and index."]
[null,null,"Nota di contenuto",null,"Preface -- Introduction to the quality systems approach to CGMP compliance -- Preparing for the audit -- Auditing and data capture -- Organizing data and reporting the results -- Developing and implementing a corrective action plan -- Developing and implementing a verification plan -- Developing and implementing a monitoring plan -- A summary for establishing a CGMP laboratory audit system -- Appendixes -- Example audit checklists: laboratory subelements -- Example template for an audit summary report -- Glossary of CGMP and audit system terms -- FDA compliance program guidance manual 7356.002 \"Drug manufacturing inspections\" -- 21 Code of U.S Federal Regulations parts 210 and 211 current good manufacturing practice regulations."]
[null,null,null,"Sommario/riassunto","The first systematic, hands-on auditing guide for today's pharmaceutical laboratoriesIn today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and "]
[{"$nulls":4},"demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. David Bliesner's Establishing a CGMP Laboratory Audit System: A Practical Guide is designed to provide laboratory supervisors and personnel with a step-by-step, hands-on audit system that they can rely"]