Zantac Expert Witnesses in Oklahoma

This FDA regulation expert earned her B.S. in Environmental Chemistry from Purchase College and her M.S. in Environmental Science from the University of Colorado Denver. She began her career with the FDA in 1987 as a Chemist in the Denver Districts Laboratory and then became a Compliance Officer in 1992, specializing primarily in medical device and biologics cases. She later managed a group of eight investigators as a Supervisory Consumer Safety Officer and then became a Compliance Officer, tasked with evaluating reports and lab analysis to determine compliance with regulation. The expert finished her FDA career as a Senior Case Review Expert, a role she held from 2008 until the end of 2015. In this position, she was responsible for reviewing and evaluating proposed judicial actions to determine if they were compliant with the requirements of the the Federal Food, Drug, and Cosmetics Act and other regulations. Currently, the expert runs her own consulting business.

This expert has successfully aided many national and international medical device companies with on-site help during FDA audits, FDA-483 responses, Warning Letter Responses, Consent Decree Corrections, ISO audits and readiness, developing and implementing compliant quality systems. She is a former FDA Regional Medical Device Expert and currently provides personalized, FDA regulatory and quality solutions and training to both small and large companies, and entrepreneurs. This expert has been invited to speak nationally, and has authored 6 publications in FDA regulatory and quality matters.

This highly-qualified expert has nearly 20 years of experience in the field of gastroenterology. He earned his BA biology from Texas A&M University and his MD from the University of Texas. He subsequently completed an internal medicine residency at the University of Texas and a gastroenterology and hepatology fellowship at the University of Alabama. He completed an additional fellowship in advanced therapeutic endoscopy/ERCP and endoscopic ultrasonography with Drs. Marc Catalano and Joseph Geenen. This expert is board-certified in internal medicine and gastroenterology, and is active in his field as a member of the American Society of Gastrointestinal Endoscopy, the American Gastroenterology Association, and the American College of Gastroenterology. He is also active in his field as an author of numerous peer-reviewed publications. Currently, this expert is the medical director of the GI Lab at a medical center, as well as a faculty member at a medical school and in the gastroenterology fellowship program for a hospital system, all in Texas.

This highly qualified expert received his Masters of Medicine and Surgery from the Seth G S Medical College & KEM Hospital. He then received his Master of Public Health from the Harvard University School of Public Health. He then went on to complete his Residency in Internal Medicine at Case Western Reserve University. He then did fellowships in Gastroenterology at Brown University and Advanced Endoscopy at Case Western Reserve University. This expert is duel board certified in Internal Medicine and Gastroenterology. He has published more than 50 peer reviewed articles in professional journals and is a frequent lecturer at Top Ranked Universities and Hospital Programs. He belongs to multiple professional organization committees including the Gastroenterology Fellowship Committee, the Scientific Program Committee and Guidelines Committee for the American Board of Gastrointestinal Endoscopy . He is currently an Associate clinical Professor at a Top Ranked University.