September 23, 2020, Bethesda, MD
John is the founder of Insight Pharma Consulting and is an expert in visual inspection. He has extensive industry experience including Sr. Manager/Team Leader for microbiology and aseptic support in Pfizer’s Global Quality Operations. He began his career as a Research Scientist with The Upjohn Company responsible for Process Analytical Technology and visual inspection. He served as the Director of Technical Support and Engineering for Pharmacia and later served as the Business Unit Director of the Center for Advanced Sterile Technology.
John holds a B.S. in Chemistry from Carroll College and a Ph.D. in Analytical Chemistry from Indiana University. He is an active member of the PDA, having served as the Chair of the Board of Directors and as the Chair of the Science Advisory Board. He organized and leads the Visual Inspection Interest Group. He is also a trainer at PDA's Training and Research Institute. John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He presents and publishes frequently in the fields of spectroscopic analysis, process analytical technology, rapid microbiological test methods and visual inspection. He is a co-author of the recently published book Visual Inspection and Particulate Control.
Rukman De Silva, Ph.D. is currently working as a Chemist/Product Quality Reviewer in FDA/CDER/OBP/Division of Biotechnology Review and Research 4. In 2007, Rukman De Silva received his PhD in Chemistry from Dartmouth College, NH, specializing in protein chemistry. After a short postdoctoral fellowship at Dartmouth College, in 2008 he joined FDA as a Staff Fellow in Dr. Gibbes Johnson’s lab. In addition to review, inspection, training and policy activities, he conducts research on studying the structure-function relationship of ErbB2 receptor at FDA. His research interest includes studying mechanisms of protein structure-function relationships and assessment of protein product quality attributes.
He is the co-organizer for the FDA Protein Aggregates Interest Group. He has received several awards including FDA/CDER team excellence awards in 2015 and 2019. He has been an invited speaker in multiple conferences in the area of visible and subvisible particulates testing in past few years. He has published in peer reviewed journals on the subject of subvisible particulate testing in biotherapeutics. Dr. De Silva also serves as a Journal of Pharmaceutical Sciences Editorial Advisory Board Member since 2018.