Monica Cahilly

  PhotoMonica Cahilly, President, Green Mountain Quality Assurance, LLC has been consulting nationally and internationally for 21 years, with specialized interest in 21 CFR Part 11 and Computer Systems Validation. Monica’s work includes data integrity inspections, application integrity policy, consent decree audits, preparing responses and corrective action plans for computer-related FDA regulatory observations, developing global and site Part 11 and computer 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 been invited to provide on-going training in the topic of Data Integrity Investigations to FDA investigators as part of the FDA Process Validation for Drug Manufacturing training program as well as to the FDA Center of Veterinary Medicine cadre. 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 ISPE, PDA, DIA, and SQA.