Jeff Yuen, MPH Jeff Yuen & Associates, Inc.

CDR Jeff Yuen is a well-respected domestic and international speaker with over 35 years of compliance and regulatory experience; Jeff was a peace officer/investigator with the State of California, Food and Drug Branch and a Consumer Safety Officer for the US FDA. During his tenure with the US FDA, he was rapidly promoted to the rank of Commander in the US Public Health Service while serving as a member of the following teams:

• FDA's Pacific Regional Biotech Team (pre-cursor to ORA Team Biologics);
• Los Angeles District Pre-Approval Manager and Drug Team Leader; and
• Foreign Inspection Cadre.

CDR Yuen served as District Drug Team Leader and Drug Pre-Approval Manager during his time with US FDA. CDR Yuen specialized in both high priority drug (PAI) and biologics (ELA and BLA) inspections. He is widely recognized as a CGMP and compliance expert by industry, CDER and CBER Office of Compliance in sterile drug manufacturing particularly with regard to inspection of biotech products, aseptic filling, quality systems, and process validation.

CDR Yuen is the recipient of numerous US Public Health commendation and achievement medals including a "Hammer Award" presented by Vice President Al Gore's Office for his participation and leadership in the area of innovative biotechnology/FDA industry outreach programs.

Since leaving the FDA in 1998, CDR Yuen has succeeded in launching a well-recognized and well-respected independent consulting firm. Jeff Yuen & Associates, Inc. is comprised of a unique balance between former FDA National Experts, specialists, investigators, chemists, biologists and microbiologists AND former industry quality systems, compliance and GXP regulatory experts.

CDR Yuen was a former President of the PDA Southern California Chapter and has sat on several executive advisory boards, was a member of IVT Board, BIOCOM's FDA Committee, UCI's Biotechnology Advisory Board, UCI Extension Advisory Board, and is a former faculty member of PDA-TRI and member of PDA's Biotech Technical Advisory Board. He is currently a member of the Dean's Leadership Council (DLC) and qualified as a Volunteer Clinical Professor with the UCI School of Pharmacy and Pharmaceutical Sciences.

CDR Yuen possesses a BS in Biological Sciences from UCI, a Masters in Public Health from UCLA, and an MBA from National University and was recognized as "Distinguished Alumni" for the School of Biological Sciences - University of CA, at Irvine.