Jeff Yuen, MPH Jeff Yuen & Associates, Inc.

Jeff Yuen, MPH

Jeff Yuen, MPH Jeff Yuen & Associates, Inc. President and CEO

CDR Jeff Yuen is a highly regarded figure in the field of compliance and regulatory affairs with over 32 years of experience. He served as a peace officer/investigator with the State of California, Food and Drug Branch, and later as a Consumer Safety Officer for the US FDA. During his tenure with the FDA, CDR Yuen achieved the rank of Commander in the US Public Health Service, holding key roles in various teams, including the FDA’s Pacific Regional Biotech Team, Foreign Inspection Cadre, and as the Los Angeles District Pre-Approval Manager and Drug Team Leader. His expertise lies in CGMP and compliance, particularly in sterile drug manufacturing, biotech products, aseptic filling, quality systems, and process validation. CDR Yuen has received numerous commendation and achievement medals from the US Public Health, including a "Hammer Award" from Vice President Al Gore's Office for his leadership in innovative biotechnology/FDA industry outreach programs. Since leaving the FDA in 1998, CDR Yuen founded Jeff Yuen & Associates, Inc., an independent consulting firm with a team comprising former FDA National Experts, industry experts, investigators, chemists, biologists, and microbiologists. He has also served as an acting transitional executive at various companies, holding roles such as Head of Quality at Althea Technologies (now Ajinomoto Althea), Executive Vice President of Global Quality for AAI Pharma / Cambridge Major Laboratories (now Alcami), Chief Quality Officer for Alexion Pharmaceuticals, Inc., and Executive VP for Hanmi Pharmaceuticals (Korea). Known for his mentoring, coaching, and teaching skills, CDR Yuen is recognized globally for his ability to collaborate with Operations and QA, drive organizational change, and emphasize the importance of "right first time" and proper root cause investigations in quality systems. He holds a BS in Biological Sciences from UCI, a Masters in Public Health from UCLA, and an MBA from National University. CDR Yuen is a past President of the PDA – Southern California Chapter and has received the "Distinguished Alumni" award from the School of Biological Sciences at the University of California, Irvine. Currently, he sits on several executive advisory boards, including the UC Irvine School of Pharmacy Dean’s Leadership/Advisory Council.