PepTalk 2014 | Toxicological Risk Assessment of Extractables and Leachables

Nandini Kashyap interviews Dr. William P. Beierschmitt, Ph.D., DABT, FATS, Regulatory Strategy Lead at Pfizer on December 20, 2013. Dr. Beierschmitt will be speaking during the 2nd Annual Extractables and Leachable conference taking place January 16-17 as part of PepTalk, January 13-17 in Palm Springs, CA. Topics include early adoption of toxicological risk assessment, risk assessment strategy, patient safety, safety issues related to extractables and leachables, role of toxicologist, plastic single use bioreactors, single use systems, risk based assessment, extractable testing, flexible manufacturing, process and product development, BPOG, USP, PQRI, standardized E&L testing, predication of leachable, toxicity and safety.