Clinical Trials Audit Preparation (Innbundet)

A Guide for Good Clinical Practice (GCP) Inspections


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Innbinding: Innbundet
Utgivelsesår: 2010
Antall sider: 246
Forlag: John Wiley and Sons Ltd
Språk: Engelsk
ISBN/EAN: 9780470248850
Omtale: Clinical Trials Audit Preparation
All clinical investigators, sponsors, and Institutional Review Boards have to comply with the applicable FDA code(s). Good Clinical Practice (GCP) Audit Preparation provides a step-by-step explanation of the FDA audit procedures for clinical trials and how a pharmaceutical company 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.

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