Jeff Yuen & Associates, Inc

Jeff Yuen & Associates, Inc Overview

CDR Jeff Yuen is 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 Consumer Safety Officer for and 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
• 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 well widely recognized as a CGMP and compliance expert by industry and CDER Office of Compliance in the area of APIs and 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, he has succeeded in launching a well-recognized and well-respected independent consulting firm. Jeff Yuen and Associates, Inc. is comprised of former FDAers with diverse background and former well respected industry quality systems, compliance and regulatory experts.