Jeff Yuen Jeff Yuen & Associates, Inc.

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

Foreign Inspection Cadre.

Los Angeles District Pre-Approval Manager and Drug Team Leader

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.

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.