Jeff Yuen, a speaker respected both domestically and internationally, dedicated over three decades to the world of regulatory compliance and quality systems before he founded his consulting firm. Known for his expertise in CGMP (Current Good Manufacturing Practice) and compliance, he has gained recognition, particularly in sterile drug manufacturing, biotech product inspection, aseptic filling, quality systems, and process validation.
While serving as a peace officer/investigator and later as a Consumer Safety Officer for the US FDA, Jeff grasped the critical nature of “right first time” practices. He witnessed the impact of thorough regulatory inspections on the pharmaceutical, biologics, biotech, and diagnostics industries. He saw the complexities of FDA regulations and identified the need for expertise in navigating these intricate regulations in the industry.
Jeff understood that companies needed to prepare for critical inspections and embrace operational excellence and performance improvement as catalysts for organizational and cultural change to flourish.
Motivated to make a difference, Jeff founded Jeff Yuen & Associates, Inc. in 1998 after leaving the FDA. His firm combines the expertise of former FDA national experts, industry specialists, and scientific professionals, providing comprehensive support for pharmaceutical quality throughout all product development and commercialization phases.
Under Jeff’s leadership, the firm has become a champion of the “right first time” philosophy, advocating for thorough root cause investigations and the implementation of meaningful Corrective and Preventive Actions (CAPA). His passion for mentoring and teaching has left a positive impact on numerous companies, equipping them with the tools for success in an era of rapid technological progress and stringent compliance standards.
A Journey from Passion to Profession
Jeff Yuen earned a BS in Biological Sciences from the University of California, Irvine (UCI), a Masters in Public Health from UCLA, and an MBA from National University. He served as the President of the PDA – Southern California Chapter and as a Board Member for the Institute of Validation Technology’s Journal of CGMP Compliance. UCI honored him as a “Distinguished Alumni for the School of Biological Sciences.”
From a young age, Jeff had a deep-rooted passion for medicine and public health, ignited by his surgeon father whom he accompanied during hospital rounds. As a teenager, he aspired to follow in his father’s footsteps.
However, despite 38 attempts, Jeff was not accepted into medical school. Instead, he gained admission into a public health program on his first attempt. As a devout Christian, Jeff saw this as a sign that God had a different path for him. He believed that God intentionally closed the door to medical school to open another one for him in public health.
This new path led Jeff to various roles in government service, health departments, and the FDA. These experiences eventually culminated in the creation of Jeff Yuen & Associates, Inc. (JYA).
Even before conceptualizing JYA, Jeff desired to make a difference and give back to society and the world. He often joked about his work compared to his father’s, saying “He had his patients, but I had the world, serving communities and countries.”
Jeff believes global citizens have much to do, whether ensuring access to healing for those in need or preserving the planet’s natural wonders. After his father’s passing, Jeff reflected on his life and future direction. For him, it’s all about giving back, and he is committed to doing his part.
Jeff Yuen & Associates, Inc.: Expertly Navigating Regulatory Compliance
Jeff Yuen & Associates, Inc. (JYA) is a public health organization offering crucial regulatory and compliance consultation. They assist pharmaceutical, medical device, biotech, and biologics companies seeking FDA approval and/or commercialization of medical products to support patients with unmet medical needs.
JYA specializes in a broad range of products, including sterile and non-sterile dosage forms, small and large molecule products, vaccines, medical devices, and combination products. Their expertise spans all GxP (Good x Practice) areas, making them a versatile industry player. (The “x” in GxP refers to the field where the guidelines and regulations apply.)
Known for their close collaboration with clients and their Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs), and Clinical Trial Laboratories (CTLs), JYA aims to keep senior management informed of deficiencies and/or potential regulatory findings. They also ensure the suitability and timeliness of Corrective and Preventive Actions taken to address gaps or deficiencies after an audit.
Jeff emphasizes, “Transparency is critical when establishing trust and long-lasting value-added relationships. We understand the importance of being collaborative, progressive, and pragmatic as a partner.”
JYA offers a comprehensive range of services, including auditing and remediation, validation, commissioning, and qualification for facility design and construction, and addressing serious compliance issues. They also provide leadership and mentorship through their Advisory Board/Executive Management & Transitional Leadership service.
Additional services include training in fundamental CGMP (Current Good Manufacturing Practice) principles, leveraging regulatory experience for submissions, Qualified Person (QP) services for European markets, project management, and support in legal situations as an expert witness.
Moreover, JYA has expertise in several areas, including biologics, cell/gene therapy, viral products, small molecule finished dosage forms, drug substances/APIs, data integrity/Part 11 and computer validation, GLP (Good Laboratory Practices), and GCP (Good Clinical Practices), medical devices and combination products, pharmacovigilance (PV), compounding pharmacies, and cosmetics, dietary supplements & nutraceuticals.
Besides, Jeff stresses the importance of properly executing client engagements and ensuring customer satisfaction at all times. Therefore, JYA is not afraid to make necessary adjustments when needed. They refuse assignments where they cannot bring the proper subject matter experts to the client, emphasizing their commitment to quality and expertise.
The Team behind JYA: A Fusion of Expertise and Experience
What sets JYA apart is its uniquely composed team. It’s a balanced blend of former regulators and industry experts who serve the pharma, biotech, and medical device industries. JYA selects its team members based on their significant achievements and experience in the regulatory agency and industry.
Key team members boast impressive backgrounds. Some have served the FDA in various capacities, such as National Experts, Level 3 Drug Specialists, Pre-Approval Inspection (PAI) Managers, Drug Team Leads, Foreign Inspection Cadre Members, Consumer Safety Officers (CSOs), Senior Consumer Safety Officers (SCSOs), Compliance Officers, CDER Review Microbiologists, and Chemists.
Furthermore, their industry experts have an equally outstanding track record. They have taught FDA courses, specialized in Data Integrity Verification Audits and Assessments, held CEO positions, led Quality and Quality Control (Chemistry and Microbiology) departments, worked on Validation, hosted successful regulatory inspections, and contributed to significant regulatory and compliance remediation projects.
A Leader Defined by Achievements and Recognition
During his tenure with the US FDA, Jeff quickly ascended to the rank of Commander in the US Public Health Service. He served on several teams, including the FDA’s Pacific Regional Biotech Team, the Foreign Inspection Cadre, and as the Los Angeles District’s Drug Team Leader and Pre-Approval Manager. In these roles, he specialized in high-priority drug (PAI) and biologics (ELA and BLA) inspections.
The US Public Health Service awarded Jeff numerous commendations and achievement medals for his work. Notably, Vice President Al Gore’s Office presented him with the “Hammer Award” for his leadership and participation in innovative biotechnology/FDA industry outreach programs.
In addition to his work at JYA, Jeff actively participates in several executive advisory boards. He continues to serve on BIOCOM’s FDA Committee, UCI’s Biotechnology Advisory Board, and UCI Extension Advisory Board. He also continues to teach at PDA-TRI.
Previously, Jeff was also a member of PDA’s Biotech Technical Advisory Board, and recently, UC Irvine’s School of Pharmacy appointed him as a member of their Dean’s Leadership / Advisory Council. His active involvement in these roles highlights his commitment to the industry and his eagerness to share his expertise.
“Long before JYA existed, God placed a burning passion and humble desire in me to make a difference and to give back to society and the world. There remains much for all of us to do as citizens of the world, whether that be working to ensure that spiritual, emotional, and physical healing is made accessible to those who are deprived or preserving the natural wonders of this planet.”
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