FDA Regulations Expert Witnesses in Oregon

This highly qualified expert specializes in engineering and regulatory affairs for medical device commercialization. She earned a BS in mathematics from Oregon State University and a MS in Medical Device and Diagnostic Engineering from the University of Southern California. This expert currently owns and operates her own medical device company where she prepares and submits FDA regulatory services 510k applications.

This Nutrition industry professional has an advanced degree in nutrition, and several years of experience involving the technical aspects of regulatory affairs, scientific affairs, product labeling, and research & development. His specialties: 21 CFR 101 (Food Labeling), 21 CFR 111 (cGMPs for dietary supplements), FTC advertising guidelines, regulatory compliance review, product substantiation, ingredient research and product development. In his current role as Manager at a Vitamin research company he is responsible for reviewing products, labeling and marketing materials for FDA and FTC compliance.

This expert has over 40 years experience in communication messages and interpretation. He currently conducts research concerned with the interpersonal tactics and message strategies that individuals use in the context of problematic social interactions. He also specializes in communicative intention and the adequacy/inadequacy of messages. This includes the question of how people are most likely to interpret messages in particular warning labels, advertising, contracts, instructions, waivers, and so forth. He has been recognized by the field as being among the "Top 1%" of the discipline's scholars in research productivity during the 1980's and 1990's. He has been an associate editor for several journals and has held several offices within the National Communication Association and Western States Communication Association. He has taught both graduate and undergraduate level courses concerned with interpersonal communication, language, message strategies, and empirical research methods.

This expert has been practicing anesthesiology at a 600 bed hospital in Southern California for nearly a quarter century. A graduate of UC Riverside, he attended medical school at Loyola Stritch School of Medicine in Illinois and thereafter completed residencies in General Surgery and Anesthesiology at Loma Linda University Medical Center. A diplomate of the American Board of Anesthesiology and an active member of the American Society of Regional Anesthesia and Pain Medicine, currently holds the post of Chief of Anesthesia at a major hospital in the Los Angeles area. He has additional experience in drug development of a safer abuse deterrent opioid currently going through the 505(b)2 FDA approval process and medical device development of a safer opioid pill dispenser currently going through the 510K class I FDA approval process.

This expert has over 10 years of experience in risk management and regulatory compliance in the financial services industry, with a focus on identifying compliance issues and implementing solutions to mitigate risk. In his work with the CFPB, he identified millions of dollars in remediation for consumers. Formerly, he worked in consumer protection roles with the Consumer Financial Protection Bureau and the California Department of Financial Institutions, as well as in compliance and risk management roles at San Diego County Credit Union and Union Bank. Currently, he is a compliance advisor with a national financial services group and is based in California.