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The document outlines the professional experience of Alanna L. Mussawwir-Bias, an experienced leader in the Biologics and Bioresearch Monitoring (BIMO) Program at the FDA. With 17 years of expertise, she has conducted both domestic and international inspections in countries such as Canada, South Africa, Russia, China, and India. Her educational background includes a Graduate Degree in Public Health Practice from Wayne State University and a Bachelor’s Degree in Biology from The College of Wooster.
During her tenure at the FDA, she served as a Supervisory Investigator in the Dallas District, Fort Worth Resident Post from June 2010 to May 2017. Her responsibilities included managing and leading a team of Consumer Safety Officers (CSOs) and administrative staff across multiple locations. She was responsible for planning, scheduling, and assigning work based on priorities and ensuring compliance with FDA regulations. She also provided technical expertise on complex inspections and sampling assignments, both domestically and internationally.
Alanna played a significant role in developing advanced program concepts and standards, particularly in regulatory programs such as BIMO, Biologics, and Drugs. She co-led BIMO Harmonization Subgroups and conducted training for FDA Investigators. Her accomplishments include CI Disqualification in 2015 and IRB Disqualification in 2016.
In her previous role at the FDA's Denver District, Albuquerque Resident Post, she provided regulatory advice and conducted complex investigations and inspections. She supported FDA operations with field exams and sample collections, managing various administrative functions.
Her work has contributed significantly to the FDA’s mission, ensuring compliance and safety in the biologics and bioresearch sectors.
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