Jeff Yuen - Biotechnology and Pharmaceutical Advisor
CDR Jeff Yuen brings nearly 20 years of compliance and regulatory experience
to QS Labs as a former government regulator and corporate industry advisor.
Jeff successfully launched his own independent consulting firm, Jeff Yuen and
Associates; a consulting firm that remains in high demand by life sciences
companies since leaving the FDA in 1998.
Jeff is widely recognized as a CGMP and compliance expert
by industry and his peers at FDA in the area of sterile (aseptic)
drug and biotech manufacturing. He serves industry as an active
compliance and regulatory expert, well-respected speaker, and
effective trainer in preparing domestic and international companies
for successful high priority new API and finished drug (PAI)
and biologics (BLA) licensing inspections.
Jeff held various progressive positions with State of California
, Food and Drug Branch and FDA for over a decade. While at
the FDA, Los Angeles District, he served as the Drug Pre-Approval
Manager and Drug Team Leader. Quickly promoted to Commander,
he has been the recipient of numerous US Public Health Service
commendations and achievement medals, including a "Hammer
Award" presented by VP Al Gore's Office for his participation
and leadership in the area of innovative biotechnology and
FDA industry outreach programs.
Jeff possesses a BS in Biological Sciences from UCI, a Masters
in Public Health from UCLA, and an MBA from National University
. He is a past So. Cal. Chapter President of the PDA, former
Board Member for the IVT's Journal of CGMP Compliance, and
former Board of Directors member for International Medication
Systems. CDR Yuen remains a faculty member for PDA-TRI.
For additional information about Jeff Yuen and Associates, please
contact Jeff Yuen.
Email
Jeff
|