Charles Emken PMM, PDP

Charles Emken is the Engineer at Agilent Technologies, Inc., Santa Clara, California, United States. He is experienced with United States Food and Drug Administration (FDA) cGMP/cGLP, 21 CFR Part 11 - Electronic Records/Electronic Signatures, International Standards Organization (ISO), and the United States Pharmacopoeia (USP) requirements and expectations and also experienced in project management with numerous years support Software Development Life Cycle activities, conducting vendor/product evaluations, requirements generation, Quality, and Regulatory risk assessment, system configuration, and change control management for both small and enterprise-class projects.