This course addresses the current state of regulatory policy related to leachables and potential leachables (i.e., extractables) organized as to drug product type. The course will also cover laboratory evaluation of potential leachables (i.e., extractables), qualitative and quantitative analysis of leachables and extractables (for both stability studies and routine quality control), and safety evaluation of leachables within the context of an overall pharmaceutical development process with special emphasis on the sensitive nature of biologicals.
Dr. Feinberg is a Director in the Development & Clinical Services business of Catalent Pharma Solutions. He has over 15 years Pharmaceutical Analysis experience and over 25 years experience in Mass Spectrometry and Organic Spectroscopy. He was a co-author on the PQRI Working Group on Leachables and Extractables recommendation “Safety Thresholds and Best Practices for Leachables and Extractables in Orally Inhaled and Nasal Drug Products (OINDPs).” After completion ofthat project, Dr. Feinberg helped develop and conducted many of the PQRI training modules both in the US and Europe. He has been an active member of the PQRI Leachables and Extractables Parenteral Ophthalmic Drug Product (PODP) working group from its inception in 2008. He has written and presented extensively on extractables and leachables issues and also on advanced analytical chemistry techniques for quantitation and characterization of pharmaceutical impurities, degradants and adulterants.
For more information on this course and to register, please visit www.eas.org.