Jodi Gatica

Background

About Jodi Gatica

Currently providing GxP consulting services for short-term projects including, BIMO (clinical trials), drug manufacturing, and dietary supplement manufacturing. Experienced Senior Quality and Regulatory Professional with a demonstrated history of working in the federal government and private sectors under pharmaceuticals, clinical investigations, dietary supplements, hemp (cannabis), and food. Skilled in quality management systems; product robustness, gap analysis, and risk assessment focused projects; domestic and international system and compliance based audits and investigations in a variety of industries falling under the jurisdiction of the U.S. Food and Drug Administration (FDA) and international Ministries of Health (MoH); regulatory submissions, technical writing, managing teams, training and development, review of qualification/validation protocols and reports, bioresearch monitoring, maintaining compliance through QMS (CAPAs, RCAs, investigations, change controls, material reviews, Management Review), and hosting/preparing for various audits.