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CDR Jeff Yuen is a well-respected domestic and international speaker with over 32 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 the area of 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 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.  

Since leaving the FDA and building his well-respected consulting firm, he has served as an acting transitional executive at several companies:  

  • Head of Quality at Althea Technologies now Ajinomoto Althea (San Diego), 

  • Executive Vice President of Global Quality for AAI Pharma / Cambridge Major Laboratories now Alcami (North Carolina),

  • Chief Quality Officer for Alexion Pharmaceuticals, Inc. (New Haven, CT) and 

  • Executive VP for Hanmi Pharmaceuticals (Korea).

CDR Yuen has become well-recognized worldwide for his unique ability to work well with others in Operations and QA. Well-respected for his mentoring, coaching and love for teaching, CDR Yuen excels at bringing out the best in companies.  With a passion for operational excellence and performance, he has often served as the catalyst for organizational and cultural "change" resulting in effective quality systems which emphasize the importance of "right first time" and proper root cause investigations and meaningful CAPA initiatives. CDR Yuen's leadership and insights along with his endless energy and special charisma have influenced, shaped, and prepared many companies and their leaders for success during this challenging era of technological advancements and stricter compliance expectations. 

CDR Yuen possesses 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 former Board Member for the Institute of Validation Technology’s Journal of CGMP Compliance.  Recently, CDR Yuen was awarded “Distinguished Alumni for the School of Biological Sciences – University of CA, at Irvine.  

CDR Yuen sits on several executive advisory boards, remains a member of the BIOCOM’s FDA Committee, UCI’s Biotechnology Advisory Board, UCI Extension Advisory Board, and continues to teach at PDA-TRI.  He was a member of PDA’s Biotech Technical Advisory Board and recently appointed as a member of UC Irvine’s School of Pharmacy, Dean’s Leadership / Advisory Council.

About: About Me
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