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Committee & Speaker Biographies

Committee & Speaker Biographies

2020 PDA Visual Inspection Interest Group Workshop

September 23, 2020, Bethesda, MD

  • John Shabushnig

    John G. Shabushnig, PhD

    Insight Pharma Consulting, LLC

    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 an instructor 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.

  • Romain Veillon

    Romain Veillon

    GSK Vaccines

    Romain Veillon is Senior Manager Visual Inspection & Leak Testing at GSK Vaccines, in Global MSAT Manufacturing Technologies. As global expert he is leading Visual Inspection performance and expertise network on multiple sites.

    He now focuses on Visual Inspection in a global function to support GSK sites for Quality Integration Lead, Technology Development, Validation Strategy, Capability assessment, Asset Management programs, Technical Watch, Performance Improvement and Develop Equipment strategy within network. He manages a network of vision experts to develop visual Inspection expertise within GSK Vaccines. Romain is now focusing in machine learning and new concept development.

    Last past 18 years he has worked in parenteral manufacturing, he has gained experience at Sanofi Pasteur, Eli Lilly and GSK Vaccines, in support to production and secondary operations projects for filling and freeze-drying.

    He also developed innovative vision systems with some academic collaboration and regular presentation to PDA conferences. 

    In 2017, Romain developed a new PDA course Mastering AVI. Since 2018 Romain is Interest Group Leader for Visual Inspection in PDA Europe.

  • Rick Watson

    Rick J. Watson

    Merck & Co., Inc.

    Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 25 years of experience in the field of process design and process modeling and is a certified Black Belt in Lean Six Sigma. Rick has spent the past eighteen years at Merck focusing on the visual inspection processes for parenteral products. During this period he led a team of engineers responsible for optimizing existing automated and manual inspection processes and developing new inspection systems. Rick's current role includes providing a global strategy and process support for visual inspection and primary packaging components for Merck manufacturing sites around the world.

  • Rukman De Silva

    Rukman S. De Silva, PhD

    U.S. FDA

    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.