Daftar Isi: Clinical trials audit preparation

Format:	Book Bachelors
Terbitan:	John Wiley & Sons , 2010
Subjects:	Drugs > Testing > Auditing Medical audit Clinical trials as topic > Standards Guideline adherence > Standards Management audit Quality control
Online Access:	http://lib.ui.ac.id/file?file=digital/20376693-Clinical Trials Audit Preparation- A Guide for Good Clinical Practice (GCP) Inspections-Fulltexts.pdf

Daftar Isi:

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.