Ann has over 25 years of experience in both the pharmaceutical and medical device arenas, from preclinical research through PMA submissions. She joined CRC in 2009 to design, implement and manage the corporate Quality System. Components include the quality structure, SOP program, CAPA system, and training program. Her expertise includes clinical process development, clinical cycle time, and process improvements. Ann performs internal and external compliance audits in accordance with audit plans and applicable regulations and provides professional guidance and leadership to ensure processes, procedures and activities are in compliance with industry standards, GCPs and other current regulations and guidance.