Monica Cahilly, President, Green Mountain Quality Assurance LLC has been consulting nationally and internationally for 28 years, with specialized interest in Data Governance / Data Integrity Assurance. Monica’s work includes investigations and assessments, application integrity policy, preparing responses to FDA observations, developing global compliance programs, and training. Monica was invited in February 2009 by U.S. FDA to present to CDER Offices of Compliance the topic of ‘Detecting Aberrant GxP Data and Handling Practices’ and has subsequently provided on-going training in Data Integrity Investigations to U.S. FDA as well as World Health Organization (WHO), Medicines and Healthcare Products Regulatory Agency (MHRA), Health Products Regulatory Agency (HPRA), Health Canada (HC), European Medicines Agency (EMA), Italian Medicines Agency (AIFA), China NMPA, Swissmedic, Pharmaceutical Inspection Co-operation Scheme (PIC/S), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Therapeutic Goods Administration (TGA), and others. Monica’s most recent interests include working in healthcare policy to prevent and detect data integrity issues as these relate to safe, effective, and cost-effective medicines. Monica has a bachelor’s degree in Biochemistry from Dartmouth College, a master’s degree in Genetic Toxicology from M.I.T., is a member of PDA, DIA, ISPE, and SQA, and is RQAP-GLP.