Globally boarded (DABT, ATS, ERT) doctorate part-time toxicology consultant with 46 years of toxicology work experience. I have extensive work background in the major employment areas of the toxicology discipline: academia, government, contract laboratories, consulting and the pharmaceutical industry environments. Toxicology consulting services are provided in multiple areas of toxicology including, but not limited to, general toxicology, occupational toxicology (e.g., OELs, ADEs, PDEs), risk assessments of extraneous matter, extractables and leachables, solvents, impurities, degradants, excipients, trace elements, metals, and genetic toxicology. I have lengthy experience with toxicology risk assessment of finished product medical devices, combination products including the finished device and individual components as manufacturing components that are used in the process stream (e.g., filters, tubing, bioreactor liners, containers, films, coatings, inks/pigments, etc.) in manufacturing the finished products. I have in the past several years and currently continue to be an invited speaker and/or SME panelist at both national and international HPAPI and Extractable &Leachables Conferences. I also have experience as a subject matter expert (SME) toxicologist in litigation events

Sudheer Singamsetty is a seasoned expert in Artificial Intelligence and emerging technologies, with over 20 years of experience spanning research, product development, and strategic advisory roles. His work has tracked the evolution of AI—from early rule-based systems to today’s cutting-edge deep learning and generative models. Known for his forward-thinking insights, Sudheer is passionate about shaping the future of AI and sharing his knowledge with diverse audiences.