000			01673nam a2200181Ia 4500
008			140223b2010 xxu||||| |||| 00| 0 eng d
020			_a9780470248850 _c0.00
082			_a615.580724 _bMIH
100			_aMihajlovic - Madzarevic, Vera
245			_aClinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections
260			_aNew Jersey _bJohn and Wiley Sons, Inc. _c2010
300			_a246p
500			_aThe Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards.This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals.
600			_aAudit Preparation
890			_aUSA
891			_aPeople - Health - Good health {QuickPic}
995			_AMIH _B009528 _CCOM-COL _D2877.19 _E0 _F049 _G102871 _H0 _I0.00 _J4443.53 35.25% _L20100814 _M3 _UC _W20100913 _XHimanshu Book Co. _ZReference
999			_c15232 _d15232