2026-November ASQ Orange Empire, Section 0701, Monthly Meeting- Nov. 10th

Join ASQ Orange Empire section for dinner and learning with the Quality community. Monthly Meeting Agenda: 5:30 - 6:00 PM Registration 6:00 - 6:15 PM Section Updates & Awards 6:15 - 7:15 PM Clinic-1 7:15 - 7:45 PM Dinner 7:45 - 8:45 PM Clinic-2 8:45 - Networking ______________________________________________________________________________ CLINIC - 1 Topic: “Phase-Appropriate Quality Systems in Early-Stage Life Sciences: How Much is Enough?” Presented by: Dr. Suparna Mishra SYNOPSIS: Early-stage life sciences companies face a persistent dilemma: build robust Quality Systems early and risk slowing innovation or defer structure and risk compliance failures later. Most organizations get this balance wrong—either over engineering processes that add little value or underbuilding systems that fail under regulatory scrutiny. This presentation introduces a phase-appropriate Quality framework tailored to early development (preclinical through Phase II), focusing on what is essential, what can wait, and what is non-negotiable. SPEAKER BIO: Dr. Mishra has over 25 years of experience in biomedical research including her most recent 10 years in Quality. She earned a Ph.D. in Pathobiology from the Keck School of Medicine, University of Southern California. While working as a postdoctoral scholar at the Children’s Hospital of Los Angeles, she received the California Institute of Regenerative Medicine grant award (CIRM) and the A.P. Giannini Medical Fellowship award for her translational research work on Cystic Fibrosis. As a Researcher at the University of California in Los Angeles, Dr. Mishra was responsible for the manufacture of autologous gene therapy products for multiple Phase 1/2 clinical trials, as well as management responsibilities for the cGMP facility and the clinical laboratories. Dr. Mishra began her career in Quality at Calimmune Inc., a company co-founded by Nobel Laureate, David Baltimore, and later acquired by CSL Behring. At Calimmune, she developed and upgraded the quality management system, including the implementation of an electronic quality management system. She has also worked at HemaCare, a Charles River Company, where she had an integral role in maintaining quality and regulatory compliance in the manufacture of donor-derived blood products. In 2020, Dr. Mishra joined Armata where she successfully built a Quality Assurance Department and implemented phase-appropriate quality systems for the conduct of clinical trials. As the Vice President of Quality, she was responsible for ensuring compliance with cGMP and GLP standards in the production and testing of investigational products, as well as ensuring GCP compliance in the conduct of clinical trials. ____________________________________________________________________________ CLINIC - 2 Topic: “Quality, Anomaly, and Oversight: Lessons from 20 Years at the USPTO and the Dawn of American Invention” Presented by: Dr. Julie Burke SYNOPSIS: Process control, quality assurance, and rigorous procedural compliance are the backbone of any sound system, whether in modern industry or government oversight. In this talk, Dr. Julie Burke draws on nearly two decades inside the U.S. Patent and Trademark Office as a Quality Assurance Specialist and whistleblower to examine how administrative practices and procedural adherence shape our patent process. Transitioning from modern USPTO quality enforcement to historical research, Dr. Burke shares surprising findings from her book, Unfettered Invention: How the X Patents Sparked Early American Technology, revealing how significant procedural anomalies, lack of standardized controls, and record-keeping oversights in the early U.S. patent system (1790–1836) ultimately set the stage for the catastrophic loss of all early American patents. Additionally, the presentation examines how artificial intelligence was leveraged to research these historical records, as well as the benefits and risks of AI adoption in modern intellectual property. Dr. Burke will address how inventors, law firms, and patent offices currently integrate AI into tech creation, drafting, and institutional operations. Attendees will gain an insider's perspective on root-cause procedural failures, the impact of quality auditing in institutional practice, and why sound quality management remains vital to safeguarding innovation. SPEAKER BIO: Dr. Julie Burke is the founder of IP Quality Pro LLC, where she provides consulting and expert witness services on patent office practice, procedures, and quality management. A former patent examiner and Quality Assurance Specialist with nearly 20 years inside the U.S. Patent and Trademark Office, she advocated from within for system-wide quality and policy reforms. Dr. Burke holds a PhD in biochemistry from the University of London and a bachelor’s degree in cellular and molecular biology from Johns Hopkins University. She previously served as a registered patent agent and patent scientist at Knobbe Martens and is a widely published commentator on intellectual property in outlets such as IPWatchdog, Law360, and The Hill. She is also co-author of Unfettered Invention- How the X Patents Sparked Early American Technology which explores the early history of the U.S. patent system—including how procedural anomalies and administrative failures led to the tragic loss of all early American patent records in the Great Patent Office Fire of 1836, and the critical quality lessons that followed.