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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Visual Inspection Forum

April 23-24, 2019, Washington, DC

  • Markus Lankers

    Markus Lankers, PhD

    MIBIC GmbH & Co KG

    Markus is one of the co-founders of MIBIC GmbH that develops rapid bacteria identification systems. Within MIBIC Markus is responsible for research and development of new spectroscopic methods for bacteria analysis. He has 25 years of experience in the field of particle identification. In 2002 he founded rap.ID Particle Systems GmbH and served as Managing Director until the sale of the company in 2018. Prior to this position, he worked as a scientist in different development departments at Schering AG, Berlin, Germany.

    Markus holds a diploma in Chemistry and a Ph.D. in Physical Chemistry from the University of Würzburg. He is an active member of the Parenteral Drug Association (PDA). Since 2003, he has supported the ‘Visual Inspection of Parenterals’ Interest Group in Europe as Interest Group Leader.

    He has served as program co-chair for the PDA Visual Inspection Forum from 2001 to 2018 in Europe and the USA.  

  • John Shabushnig

    John G. 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), having served on the Board of Directors (2003-2011, 2016) and 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 the subjects of 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.

  • John Ayres

    John D. Ayres, MD

    Pharma Safety Solutions, LLC

    Dr. John Ayres received his undergraduate degree in chemistry from Butler University in 1979 then received his Doctor of Medicine degree from Indiana University School of Medicine in 1983. He completed his residency at the Indiana University Medical Center and is Board Certified in Internal Medicine.

    Subsequently, Dr. Ayres obtained a Law Degree from Indiana University Bloomington in 1993 and was admitted as member of the Indiana and Federal bar before returning to the Indiana University School of Medicine as a faculty member.

    In addition to his clinical duties, Dr. Ayres established a risk management department and served on the Medical Center's Institutional Review Board (IRB). He has had clinical practices in both internal medicine and occupational and environmental medicine and has served in various consultative roles to both industry and government agencies. 

    For 15 years, Dr. Ayres has served as the Health Hazard Evaluation physician and Sr. Medical Fellow, Product Safety Assessments for a multi-national pharmaceutical company. In this role he worked closely with product development, manufacturing, quality, and pharmacovigilance to evaluate the human safety risk potentially associated with Critical Quality Attributes (CQAs), manufacturing and environmental excursions, linked to product complaints, or related to counterfeit medication issues including surveillance, risk assessment and management, and regulatory-compliance functions. Dr. Ayres now provides limited consultative assessments on these issues. He currently serves on the USP Visual Inspection Expert Panel and PDA’s Scientific Advisory Board.

  • Roy Cherris

    Roy T. Cherris

    Bridge Associates International LLC

    Roy T. Cherris has over 40 years of process and QA experience in microbiology, microscopy and inspection. He is a founding member and Managing Partner of Bridge Associates International consultancy in Princeton, NJ. He is also Chief Science Officer of InQuest Science which troubleshoots product defect issues and provides training and guidance on particulate matter and physical defect control, optimized inspection and defect life-cycle tracking systems.

    Roy has studied forensic microscopy extensively at the McCrone Research Institute in Chicago.
    He is a respected SME in the field of visual inspection systems and investigative microscopy for particle or defect source identification and mitigation. Roy served as the chair of the PDA task force for evaluating particulate matter in Difficult to Inspect Parenteral products which developed PDA TR-79 and he is an active member of the USP Expert Panel for Visual Inspection of parenterals which produced USP-790 and USP-1790.

    Current publications include the PDA distributed book titled “Visual Inspection and Particulate Control” 2016, Davis Healthcare International Publishing, LLC, Bethesda, MD.
    ISBN: 1-933722-93-2

  • Rob Miller

    Robert J. Miller

    Pfizer Inc.

    Rob Miller has been with Pfizer Global Quality as a subject matter expert in visual inspection since 2013. Prior to this role he worked as an automation/controls engineer and inspection process engineer for 22 years. He is responsible for supporting Pfizer’s aseptic network with internal quality standards and policy related to manual and automated visual inspection. In addition, he reviews aseptic site inspection processes for compliance to current guidance and is frequently busy with all things related to glass. Rob has a B.S. in Electrical Engineering, an M.S. in Engineering Management and a Graduate Certificate in Applied Statistics.

  • 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 Watson

    Merck & Co., Inc.

    Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 22 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 fourteen 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.

  • Gerald Budd

    Gerald W. Budd

    Phoenix Imaging Ltd.

    Mr. Budd is the founder and President of Phoenix Imaging, Ltd. The company was founded in 1986 to investigate the capability of using machine vision technology to isolate imperfections in tubing vials. He has managed numerous research projects for the development of specialized illumination systems and image processing technologies used in the automation of inspection equipment. He has been exhaustively involved in the development of Standard Lighting Environments and Advanced Particle Detection / Measurement technologies for the past 20 years. He holds a B.S. degree from the Eastern Michigan University in Physics and Chemistry with a concentration in Optical Instrumentation. Mr. Budd holds multiple patents for advanced image processing techniques in Optical Shape Recognition, Instrumentation, Advanced Lighting Systems and Particle Measurement Technologies. His company currently manufactures over 15 models of Manual Inspection Booths (MIB’s) that are used worldwide. Phoenix Imaging is a leading supplier of Referee Level Particle Standards (RLPS™) seeded in vials, cartridges, syringes and IV bags for use in calibration of inspection equipment and the appraisal/qualification of human inspectors.

  • Andrea Cedrola

    Andrea Cedrola

    Patheon, part of Thermo Fisher Scientific Inc.

    Andrea Cedrola was born in 1967 in Oleggio, Italy. He graduated in Chemistry from “Università degli Studi di Milano” (Milan, Italy) with a Master Thesis in collaboration with the EU Joint Research Centre based in Ispra (VA).

    His work experience in the pharmaceutical industry started in 1997 in the area of Plant and Equipment Qualification. He has since then developed remarkable experience in the qualification steps (FAT, SAT, Commissioning, IQ, OQ, PQ) both in the sterile area (lyophilized and PFS) and on solid dosage form and packaging equipment, with major focus on autoclaves, freezers, climatic chambers, ovens, tunnels, filling and capping machines.

    In 2003 he joined the Equipment Validation department of Patheon, part of Thermo Fisher Scientific Inc. In this role, he focused on the the qualification of Cleanrooms Areas/Clean Air Device and on Visual Inspection Systems (AVI machine, OCV/OCR, linear and 2D barcode readers). Specifically, he has strong experience in the activities of defective units preparation, recipes fine tuning and qualification activities for lyophilized and liquid products (vials), syringes and cartridges.

  • Mary Lee Ciolkowski

    Mary Lee Ciolkowski, PhD

    Bausch + Lomb

    Mary Lee Ciolkowski has 20+ years of experience in materials characterization and technical elements of maintenance of business activities within the pharmaceutical industry beginning her career with the Upjohn Company in the early 1990s. She manages all laboratory activities to support forensics investigations applied to particulate and foreign matter for the pharmaceutical and medical device businesses at Bausch + Lomb. She received a Ph.D. in Analytical Chemistry from the University of North Carolina at Chapel Hill.

  • Nathan Cox

    Nathan Cox

    KYMANOX

    Mr Cox has been with Kymanox since 2016 and currently leads the Quality Engineering group, responsible for combination product development and compliance. In his previous role, he managed the Process Engineering group, in which he was responsible for overseeing the development and implementation of a Visual Inspection process of difficult to inspect parenterals across multiple manufacturing sites, including process and procedure development, equipment qualification, and process validation. Mr. Cox has a decade of experience within the life sciences industry predominantly in the process development and technical operations space. He holds a degree in Biomedical Engineering from North Carolina State University.

  • Jorge Delgado

    Jorge Delgado

    Amgen

    Mr. Delgado joined Amgen in 2004 as Senior Engineer responsible for the maintenance and the validated state of Fill & Finish manufacturing equipment. He then was transferred to the Process Development function as Principal Engineer in Drug Product, responsible for the implementation of a hybrid single use and stainless-steel product transfer system in an isolator based aseptic operation. In his current role as Senior Manager in Process Development, he leads a team which continually improves the inspection and packaging operations through innovation. Most recently, after a successful implementation of an automatic visual inspection line for protein-based products, the team have been testing the application of Deep Learning in the inspection of pre-filled syringes to further improve the process.

  • Amber Fradkin

    Amber H. Fradkin, PhD

    KBI Biopharma, Inc.

    Amber received her Ph.D. in Chemical Engineering within the Pharmaceutical Biotechnology Program with a specialization in the field of immunogenicity of therapeutic protein aggregates at the University of Colorado at Boulder. Amber also holds a Masters in Science from the University of Colorado at Boulder plus a Bachelors of Science from the Colorado School of Mines. Amber currently holds the position of Director at KBI Biopharma where she manages the Particle Characterization Core that specializes in analytical methods for quantifying, characterizing and identifying submicron, subvisible and visible particulates. Previously, at Amgen, Amber was a Scientist within the biomolecular structures and interactions group where she supported biophysical characterization of protein products with a specialty in subvisible particle characterization and identification. She managed subvisible particle characterization for all commercial and late stage clinical products and authored particle characterization sections of numerous regulatory filings. She has over 12 years of experience (8 years industry) with analytical method development and validation, formulation and stability strategy, and protein biophysical characterization. Prior to Amgen, Amber’s experiences include analytical and formulation development for Merck & Co. and collaborations with BaroFold, Inc. to employ high hydrostatic pressure to refold proteins and control subvisible particles.

  • Massimo Frasson

    Massimo Frasson, PhD

    Brevetti CEA Spa

    After achieving a Master Degree in Mechanical Engineering, Mr. Frasson worked for several international companies in the automation industry.

    He joined Brevetti C.E.A. in the year 2000 as Mechanic Systems Design Manager.

    From 2004 he undertook the technical management of the Company and later on in 2007 he begun the restructuring of Brevetti C.E.A.'s production and the expansion of the entire range of products by introducing new vision’s technologies.

    In the same period he was coordinating and supervising a special department dedicated to the the pharmaceutical process analysis through the development of artificial vision systems using also neural algorithms.

    On 2010 he became responsible of the whole operations process and in February 2014 he has been appointed as the General Manager of Brevetti CEA Company.

  • Ian Jehring

    Ian T. Jehring

    Merck & Co., Inc.

    Ian Jehring graduated from Iowa State University with a bachelor’s degree in Chemical Engineering and a Master’s Degree in Biomedical Sciences. Ian has 5 years of experience in the pharmaceutical industry providing support for the production of sterile parenteral products. He has 3 years of experience with visual inspection, including automated incoming component checks and finished product inspection.

  • Ron Lawson

    Ron Lawson

    Prime Results

    Mr. Lawson has spent the past 30 years involved in the design, development, and life cycle management of automated inspection systems in the Pharmaceutical industry. For the past 5 years, Mr. Lawson has been the Director of Operations at Prime Results where they have developed innovative tools to simplify qualification tasks and to build in continuous improvement methods for automated inspection. Prior to Prime Results, Mr. Lawson was a founder of Seidenader Vision where, as it’s President, he led the development of the inspection stations on the industry’s first automated cosmetic inspection machine as well as the first automated LYO inspection machine. While with the Seidenader organization, Mr. Lawson was named Director of the Global Innovation Group who had the responsibility to research and analyze technologies that could prove useful in Pharmaceutical inspection applications.

  • Nicola Mauriello

    Nicola Mauriello

    MSD international GmbH

    Nicola Mauriello graduated from University of Naples “Federico II” with a Master of Science in Chemistry and Pharmaceutical Technologies. Nicola has been with MSD since 2016 starting in the External Manufacturing Quality Assurance supporting, among others, batch release activities. He recently joined MSD Global Technologies Operation on 2017, becoming the technical responsible for two CMO taking all the relative liabilities; as for example manage projects, CMO-initiated changes, etc. Currently, Nicola is focusing in process validation, especially in the visual inspection step making him discover a growing interest in this area.

  • Soren Meyer

    Søren C. Meyer, M.Sc.

    InnoScan A/S

    Søren C Meyer holds a Master of Science in Opto-Mechanical Engineering, with specialty in gas lasers.

    He has worked 10 years in the graphical industry, designing machines for optical exposure of serigraphy printing screens and offset printing plates.

    Søren joined InnoScan in 2005 and have designed a substantial part of the mechanics in the current InnoScan High speed Inspection machines. Søren have designed many of the optical inspection stations used on the InnoScan Inspection Machines.

    Søren holds the position as Mechanical and Hardware Engineering Manager at InnoScan, and is responsible for all Mechanical, Optical and Hardware development activities on Inspection Machines at InnoScan. 

    InnoScan is located in Aarhus, Denmark.

    In 2013, InnoScan became a part of Stevanato Group, with headquarter near Venice, Italy.

  • R. Douglas Ross

    R. Douglas Ross, MD, MBA

    Doug’s medical career started in obstetrics/gynecology and maternal-fetal medicine. In 1999 he made a career transition to the pharmaceutical industry and became actively involved in the medical assessment of product quality deviations and their effects on patients.

  • Joanny Salvas

    Joanny Salvas

    Pfizer Inc.

    Joanny Salvas has a bachelor’s degree in biotechnological engineering and M.Sc.A. in chemical engineering and is a certified 6sigma black belt and project manager (PMP). She is currently a Manager in the Global Engineering PAT team at Pfizer, and has been working in that field going on 10 years. She is responsible for the implementation of Process Analytical Technologies (PAT) in several Sterile Injectible sites and supporting network-wide initiatives. She currently is heavily involved in developing and implementing NIR-based manual and automated inspection methods to improve defect detection and rejection. Her personal interests include photography, travel and running.

  • Antonio Scatena

    Antonio J. Scatena

    Gateway Analytical

    Mr. Scatena has been with Gateway Analytical since 2010 and was responsible for helping establish their particulate identification laboratory. He has held the roles of scientist and laboratory manager, responsible for the day-to-day operations of the laboratory and the investigational testing for pharmaceutical clients. Today, Mr. Scatena oversees sales and business operations and works as a scientific liaison between pharmaceutical clients and the laboratory for particulate matter investigations.

  • Christian Scherer

    Christian A. Scherer

    Seidenader Maschinenbau GmbH

    Christian completed a technical apprenticeship at Seidenader Maschinenbau before visiting the University of Supplied Science in Munich.

    He graduated in 2009 with a diploma in Business and Engineering before spending one semester in Seidenader's subsidiary SV Research in Harrisburg, USA and at the University of Plymouth, England.

    From September 2009 to May 2015, Christian was Area Sales Manager at Seidenader Maschinenbau GmbH in the Business Unit Inspection Machines. Since May 2015, he has been Head of Sales with the responsibility for the sales department of the Seidenader Business Unit Inspection Machines.

  • Aaron Shirkey

    Aaron J. Shirkey

    Merck & Co., Inc.

    Aaron Shirkey graduated from the Virginia Polytechnic and State University with a bachelor's degree in Electrical Engineering. Aaron has more than 15 years of experience in the pharmaceutical industry including more than 10 years in the automation field and over 3 years focusing on the visual inspection processes for parenteral products. Currently, Aaron works in the Technical Operations department where he provides support for manufacturing filling operations which includes vision inspection.

  • Joseph Straub

    Joseph A. Straub

    Merck & Co., Inc.

    Joseph Straub graduated from the Pennsylvania State University with a bachelor's degree in Engineering Science and Mechanics. Joe has more than 20 years of experience in the pharmaceutical and semiconductor industries, including the last 10 years at Merck focusing on the visual inspection processes for parenteral products. Currently, Joe works in the global technology organization where he provides support for vision inspection and primary packaging components to Merck’s manufacturing sites and partners around the world.

  • Jonas Hoeg Thygesen

    Jonas Hoeg Thygesen, PhD

    Novo Nordisk Pharmatech A/S

    Jonas Hoeg Thygesen has been with Novo Nordisk Pharmatech since 2012. He is area specialist in the Novo Nordisk Pharmatech Microanalysis Centre, a center of excellence in Novo Nordisk for particle identification and characterization. Here he works with microscopy, microanalytical techniques and develops new analytical methods for material identification and characterization. Among his areas of expertise are spectroscopy, microscopy and advanced data analysis (chemometrics). He holds a Ph.D. from University of Copenhagen within Process Analytical Technology (PAT).

  • James Veale

    Jim Veale, PhD

    LIGHTHOUSE Instruments

    Jim Veale is the founder and President of LIGHTHOUSE Instruments. He received his PhD in Physics from the University of Virginia. His research and business interests are in developing laser spectroscopic methods for unmet needs in the pharmaceutical industry. His current focus at Lighthouse is on developing laser headspace analysis systems for container closure integrity, process monitoring, and quality assurance of sterile pharmaceutical products.

  • Andres Velez

    Andrés Vélez

    Bristol-Myers Squibb, Manati PR

    Andrés Vélez earned a bachelor’s degree in Electronics Engineering Technology from the University of Puerto Rico and has 20 years of experience in the pharmaceutical industry. Currently works as Senior Inspection Technology Specialist for Bristol-Myers Squibb (BMS), Manatí PR, where he is primarily responsible for vision systems tuning, characterization and validation of automated visual inspection (AVI) machines. His technical expertise on vision systems has been crucial for the implementation and continuous improvements of automated visual inspection for different vial (3cc up to 50cc) and syringe (0.4mL to 1mL) product presentations. He has significantly contributed to the reduction of false rejects/ejects from syringe and vial automated visual inspection machines as part of BMS continuous monitoring and improvement program. Under his leadership, the BMS Manatí team received a Gold Award in the Quest 2018 Operational Excellence competition at Ponce, PR.

  • Hailin (Sheena) Wang

    Hailin (Sheena) Wang, PhD

    FDA

    Dr. Sheena Hailin Wang is currently a chemistry reviewer in the office of new drug products (ONDP) in the Center for Drug Evaluation and Research (CDER), and has been with the agency since 2013. She has reviewed many submissions for injectable drug products including complex drug substances and products containing nanomaterials. Sheena has been involved in the guidance development for Inspection of Injectable Products for Visible Particulates Prior to joining FDA, Sheena worked at Novartis vaccine and Diagnostics where she was a formulation development scientist and process/product development lead with expertise in protein formulation and nanoemlusion preparation.

    Sheena trained in chemistry and received her Ph.D. in Pharmaceutical Sciences from the University of North Carolina at Chapel Hill with focus on process engineering and particulate sciences.

    In addition, Sheena is a member of the Visible and Subvisible Particulate Matter Expert Committee of the United States of Pharmacopeia. 

  • Steven Wardell

    Steven Wardell

    ATS Automation

    With a Bachelor’s degree in Mathematics and Computer Science, I started my career 30 years ago at ATS programming controllers and equipment used in high precision assembly systems. Whether programming, integrating, or managing the integration of high accuracy positioning stages, vision systems or related controls and instrumentation, I've been part of an automation company that has expanded from a one man shop to a worldwide industry leader today. For the last 8 years, I have been directing the Imaging group at ATS. Our core team of vision engineers support all of our automation facilities worldwide and provide 100’s of custom machine vision solutions each year to the Life Sciences, Automotive, Energy and Consumer Goods manufacturing industries.

  • Jose Zanardi

    José M. Zanardi, PhD

    Bosch Packaging Technology

    Zanardi is Senior Manager at Bosch Packaging Technology, where he is responsible for vision inspection development and applications at the Center of Competence for Vision Technology, located in Japan. In this position he has been project manager for platform development of automated inspection machines, and also responsible for vision technology applications in customer projects.

    Before joining the Bosch Packaging division, Zanardi worked at Bosch Corporate Research where he was responsible for the Japanese branch of that unit.

    He has a doctoral degree in materials science, with specialty in spectroscopic characterization of defects in semiconductor materials.

  • Elisabeth Zybczynski

    Elizabeth Zybczynski

    Baxter Healthcare

    Elizabeth has been with Baxter for 10 years and held various roles in R&D, Quality, and Risk Management. Elizabeth is currently the Director of Production and Process Controls for Baxter’s Global Manufacturing Network and currently leads Baxter’s Global Visual Inspection Harmonization Program. Prior to joining Baxter, Elizabeth worked in the Oil & Gas, Aerospace, and Automotive Industries.