PDA Visual Inspection and Particle Control in Parenteral Drug Product Manufacturing Webinar 2024

Featured Presenters

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  Antonio Burazer

  Global Head Visual Inspection & Particle LCM, Takeda Pharmaceuticals International AG

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  Antonio Burazer

  Takeda Pharmaceuticals International AG

  Antonio Burazer joined Takeda in 2010 where he has overseen visual inspection and secondary packaging processes at a multi-product manufacturing facility in Vienna, Austria. In 2019 he transitioned to Global Quality, taking over responsibility for visual inspection and particle life cycle management globally for Takeda. He is engaged in collaborating with experts across the industry and strives for continuous improvement, guided by the ultimate goal of achieving zero particles in parenteral products.
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  Rukman S De Silva, PhD

  Policy Lead, OPQ/OPPQ/CDER, U.S. FDA

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  Rukman S De Silva, PhD

  U.S. FDA

  Rukman De Silva, Ph.D. is currently working as a Policy Lead in the U.S. Food and Drug Administration (FDA)/ Center for Drug Evaluation and Research (CDER)/ Office of Pharmaceutical Quality (OPQ)/ Office of Policy for Pharmaceutical Quality (OPPQ)/ Division of Internal Policies and Communications (DIPAC), Branch II. 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 the FDA/CDER/OPQ/Office of Biotechnology Products (OBP). At OBP, he conducted chemistry manufacturing and control (CMC) review and inspectional activities related to biological products submitted to the FDA. In 2022, he joined FDA/CDER/OPQ/OPPQ/DIPAC, Branch II, where he conducts FDA policies and program development activities related to pharmaceutical quality. Dr. De Silva has received several awards including FDA/CDER team excellence awards in 2015 and 2019. He has been an invited speaker at multiple conferences in the area of visible and subvisible particulate testing in the past few years. He has published in peer-reviewed journals on the subject of subvisible particulate testing in biotherapeutics. Dr. De Silva also served as a Journal of Pharmaceutical Sciences Editorial Advisory Board Member since 2018.
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  Atanas Koulov, PhD

  Chief Scientific Officer, Clear Solutions Laboratories AG

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  Atanas Koulov, PhD

  Clear Solutions Laboratories AG

  Atanas Koulov has more than 15 years of experience in pharmaceutical drug product development from Roche/Genentech, Novartis, and Lonza, where he has held positions with increasing responsibilities up to Senior Director leading the Drug Product Analytical Development & QC organization of Lonza. Atanas is a co-founder and CSO at Clear Solutions Laboratories, a service organization helping Pharma and Biotech partners tackle challenges related to particle control. His focus areas are DP control strategies, particle contamination and control, forensic chemistry, analytical development, and quality control. He has authored more than 50 scientific publications and book chapters.
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  John G Shabushnig, PhD

  Principal Consultant, Insight Pharma Consulting, LLC

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  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 BS in Chemistry from Carroll College and a PhD 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 is leading 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.

Presenters

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  Roman Mathaes, PhD

  Clear Solutions Laboratories

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  Roman Mathaes, PhD

  Clear Solutions Laboratories

  Roman Mathaes is CEO of Clear Solutions Laboratories. Before that he was Head of Pharmaceutical Services at Lonza Drug Product Services. In this role he was responsible for pre-clinical Drug Product manufacturing for vials, prefilled syringes and ampoules. He also lead the packaging and combination product development department and the lab automation group. Roman joined Lonza from Roche. He is a Pharmacist by training and holds a PhD in Pharmaceutical technology from University of Munich, as well as an MBA.