Robert G
Audits: GLP, GMP, ISO, Quality System Inspection Technique (QSIT) & Quality System Regulation (QSR) audits. CAPA, Design Controls, Environmental Monitoring, FDA, FDA-483 and Warning Letter responses, ISO-13485, ISO-9001, ISO-9002, ISO-Medical Device Directive (MDD), Quality Assurance, Regulatory Affairs. ................
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