Jeff Yuen & Associates, Inc. Information

A well-respected domestic and international speaker with over 25 years of compliance and regulatory experience; Jeff was a peace officer/investigator with the State of California, Food and Drug Branch and a CSO for and the FDA. 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); • District Pre-Approval Manager and Drug Team Leader; and • Foreign Inspection Cadre. Widely recognized as a CGMP and compliance expert by industry and FDA's Office of Compliance. Recipient of numerous US Public Health commendation and achievement medals including a “Hammer Award” presented by Vice President Al Gore’s Office for leadership in the area of innovative biotechnology & industry outreach programs. CDR Yuen is a past President of the PDA - Southern California Chapter, a former Board Member for the IVT's Journal of CGMP Compliance, and receipient of "UCI Distinguished Alumni for the School of Biological Sciences" . CDR Yuen sits on a number of 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. Jeff Yuen and Associates, Inc. is comprised of former FDAers with diverse background and former industry quality systems, compliance and regulatory experts.