Terri P. Kelly, RN, MSQA, CCRA, CQA has over twenty-two years of experience in clinical research, with eighteen years as a Consultant to the pharmaceutical and medical device industries. She has conducted international and domestic audits/evaluations of IRBs/IECs, Investigator sites, Phase I facilities, CROs, central ECG facilities, IVRS, pharmaceutical/device in-house processes and systems, Data Management, SOPs, FDA Part 11 electronic systems, HIPAA Privacy, HIPAA Security, clinical laboratories, IND submissions, PMA submissions and other statistical reports to assess compliance with FDA regulations, ICH Guidelines and international/local requirements. She has experience facilitating FDA BIMO inspections and training Investigator sites, CRAs, IRBs and industry personnel in all aspects of Good Clinical Practice.