Speakers

Ileana Elder is the Incidents, Recalls, and Shortages Branch Chief, in the Division of Supply Chain Integrity, in the Office of Drug Security, Integrity, and Response in CDER’s Office of Compliance (OC). In this position, Ileana provides operational and administrative direction to a team of over ten regulatory officers who are responsible for the review and classification of recalls to facilitate removal of unsafe and ineffective drug products from the U.S. market, the review of shortage proposals from Industry to minimize drug supply disruption of medically necessary products, and the coordination of CDER OC’s response to incidents and emergencies that could affect the U.S. drug supply.
Before joining CDER, Ileana spent two years as a reviewer of premarket submissions for in vitro medical devices and eight years as a Post-market Team Leader in the Center for Devices and Radiological Health (CDRH). As a Team Leader, Ileana led a team of over twenty regulatory reviewers and consumer safety officers who performed compliance activities such as recall classifications, manufacturing facility site inspections, review of medical device adverse event reports, and review of complaints associated with various medical devices such as blood glucose monitoring systems, pharmacogenomics tests, pregnancy and fertility tests, and cardiac/heart failure markers tests.
Ileana received a Bachelor of Science (B.S.) degree in Industrial Chemistry from the University of Puerto Rico and a doctoral degree (Ph.D.) in Biomedical Sciences from the University of Florida. She is expected to complete a Juris Doctor (JD) degree in June 2026 from the Catholic University of America, Columbus School of Law. Ileana is an American Society for Quality (ASQ) Certified Quality Auditor (CQA). She also has a U.S. Regulatory Affairs Certification (RAC) and is a certified Six Sigma Green Belt by the Regulatory Affairs Professionals Society (RAPS).
In her free time, Ileana enjoys spending time with her two young kids and husband. She loves camping and exploring new hiking trails at national parks in the area.