John Shabushnig, PhD, Insight Pharma Consulting, LLC.
John is the founder of Insight Pharma Consulting, providing expert guidance in all aspects of visual inspection. He has over 30 years of industry experience including Sr. Manager/Team Leader in Pfizer’s Global Quality Operations where he was responsible for providing microbiology and aseptic manufacturing technical support. He began his career as a Research Scientist with The Upjohn Company responsible for Process Analytical Technology (PAT) and visual inspection. He served as the Director of Technical Support and Engineering for Pharmacia with responsibility for sterile and non-sterile technology transfer and process improvement, package engineering and automation and was promoted to the position of Business Unit Director of the Center for Advanced Sterile Technology (CAST).
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 Parenteral Drug Association (PDA), currently serving on the Board of Directors (2003-2011, 2016) and previously as Chair (2008-2009) and has served on the Science Advisory Board (SAB) (as a member 2004-2016) and as Chair (2012-2014) and Vice-Chair (2010-2011, 2015). He organized and continues to lead the Visual Inspection Interest Group. He is also an instructor at PDA's Training and Research Institute (TRI). John serves on the United States Pharmacopeia (USP) Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He has published and presented numerous papers on spectroscopic analysis, process analytical technology (PAT), rapid microbiological test methods and the visual inspection of pharmaceutical products. He is a co-author of the recently published book Visual Inspection and Particulate Control.
Ronald Leversee, Perrigo Company
Ron has over 30 years of experience in pharmaceutical manufacturing with over 15 years of direct operations leadership experience in parenteral products with specialization in Freeze Drying, Visual Inspection and Packaging operational areas. He has experience with sterile vial, pre-filled syringe, and various liquids OTC processes and is a Certified Quality Auditor through the American Society of Quality. He has spent the past 9 years presenting and instructing various Visual Inspection topics and courses through the PDA Visual Inspection Forum and Visual Inspection Training Course in both Berlin and the Training and Research Institute (TRI) in Bethesda, MD. Ron has an Associate in Applied Science Degree in Electronics Technology from Kalamazoo Valley Community College, Bachelor of Science degree in Manufacturing Engineering and Masters of Science in Engineering Management both from Western Michigan University. He currently resides in Kalamazoo, MI.
Matthew Ostrowski, Pfizer, Inc.
Matt was hired by Pharmacia in 1998 as a Packaging Line Coordinator in the Dry Products Department working mainly on the Blisters and Tablet lines. In 1999 Matt became an Instructor for Pharmaceutical Manufacturing where he was responsible for training, SOP documentation, and revisions for the entire Packaging Department. In 2000 Matt was promoted to Production Coordinator in Sterile Inspection, and in 2002 he took on the role as the Inspection Supervisor which he held until 2013.
In January of 2013 Matt’s role within Pfizer changed from Supervisor to Process Technologist for the Injectable Inspection Department. In his current role, Matt’s responsibilities include process improvement, regulatory compliance, and the subject matter expert for visual inspection at the site and across the Pfizer Network. During this time Matt has had a number of developmental opportunities including; 2 years in the Aseptic Processing /Filling and Freeze Dry Department, and assigned to two projects at two separate Pfizer sites. The first was to assist with a new plant startup and product launch, and the second was at another site to develop a visual inspection process and inspection line improvement project. Along with his normal job duties Matt is a member and Instructor for the Parenteral Drug Association teaching courses in Visual Vial Inspection and Aseptic Processing. In 2009 Matt graduated from Spring Arbor University with a Bachelor’s Degree in Business.