Medical Product Quality Systems
Learn about the essential elements of Quality System Regulations (QSR's) and Good Manufacturing Practices (GMP's), how there is a commonality between them, and how to develop a global approach to Quality Systems in order to satisfy international requirements of ISO 9001:2000 and ISO 13485:2003. A detailed analysis of these systems and practical 'how to' recommendations and approaches are presented, with particular emphasis on the United States Food and Drug Administration (FDA) QSR's and GMP's.
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