Founder's Biography Jeff Yuen

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 the U.S. FDA. During his tenure with the U.S. FDA, he was rapidly promoted to the rank of Commander in the U.S. 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 widely recognized as a CGMP and compliance expert in the industry, including 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 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 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.

Public Health Service Awards and Recognition

PHS Commendation and Achievement Medals - 1998
Recipient ORA/FDA Team Award of Merit - 1998
Vice President Al Gore's Nat'l Performance Review Hammer Award - 1996
PHS Commendation and Achievement Medals - 1995
FDA Investigator of the Year Candidate - 1995
Unit Commendation Medal - 1995

Click here to see a full listing of Jeff's Public Health Service Awards

Areas of Expertise

Auditing, Training and Inspections

  • GMP Auditing
  • GMP Training

Inspections and Audits

  • Warning Letter and Regulatory Strategic Consultation
  • Mock Preapproval Inspections (PAI)
  • CMO Auditiing

Regulatory Submissions Support

  • BLA
  • NDA
  • ANDA
  • CMC

Technical Project Management

  • Project Management Overview
  • Technology Transfer Review
  • Scale-Up Review
  • Validation Review

Product Types

  • Biologics
  • Small Molecules
  • Sterile Products
  • APIs