Skip To The Main Content
Committee & Speaker Biographies

Committee & Presenter Biographies

2022 PDA Visual Inspection Forum

26-27 April 2022

  • 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, PharmD

    GSK Vaccines

    Romain Veillon is Director 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 Quality Integration Lead, New 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 innovation management with new AVI-LT asset deployment.

    For the past 22 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 collaborations and regular presentation to PDA conferences.

    In 2017, Romain developed a PDA course "Mastering AVI". Since 2018 Romain is Interest Group Leader for Visual Inspection in PDA Europe. Since 2019, Romain co-lead task force to prepare a point to consider document for AI applied to Visual Inspection. In 2020 Romain received PDA James P. Agalloco Award for educational training.

  • John Ayres

    John D. Ayres, MD

    Pharma Safety Solutions, LLC

    Dr. John Ayres received his undergraduate degree in chemistry from Butler University and a Doctor of Medicine degree from Indiana University School of Medicine. He completed his residency at the Indiana University Medical Center and is Board Certified in Internal Medicine. He obtained his Doctor of Jurisprudence from Indiana University-Bloomington and is admitted to practice law in both Indiana state and Federal courts.

    For 15 years, Dr. Ayres 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 issues related to the clinical implications of product quality attributes and variability surrounding CQAs with biopharmaceuticals in addition to safety-related compliance matters. He currently serves on the USP Visual Inspection Expert Panel and PDA’s Scientific Advisory Board.

  • Florian Krick

    Florian Krickl

    VITRONIC

    Florian joined Vitronic’s Healthcare Division in 2018. He is responsible for automated visual inspection solutions for pharmaceuticals and medical devices. The main focus of his work as a Product Manager is the identification of process requirements in difficult to inspect products and translating into new standardized solutions.

    Before joining Vitronic, Florian gained experience in medical device, hygiene and environmental technology industries. He holds an MBA and an engineering degree in Technical Health Care.

  • 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 U.S.

  • Hanns-Christian Mahler

    Hanns-Christian Mahler, PhD

    ten23 Health

    Dr. Mahler obtained his venia legendi (German Habilitation) from the University of Frankfurt/Germany in 2010 and is adjunct faculty and lecturer at the universities of Frankfurt (Germany), Kansas (Lawrence, US) and Basel (Switzerland).

    He was elected an AAPS Fellow in November 2013. His work experience includes early- and late-stage/commercial and line extension formulation development, primary packaging and device development, drug delivery, Drug Product process development, process characterization and validation, transfer to clinical and commercial drug product production and production support and preclinical and clinical (phase 1-3) Drug Product GMP manufacturing of parenteral dosage forms of biologics, small molecules, peptides and oligonucleotides.

    Prior to his consultancy, he was with Lonza and Roche. From2000-2005, Dr. Mahler was working at Merck KGaA, Darmstadt, Germany as Principal Formulation Scientist, Lab Manager for Protein Formulation Development and Clinical Trial Manufacturing and CMC Team leader for Erbitux during its submission and launch phase.

    Dr. Mahler studied Pharmacy at the University of Mainz, Germany, holds in Ph.D. in Toxicology from the Institute of Pharmacy, University of Mainz and Pharmacist specialization degrees in Toxicology & Ecology and Pharmaceutical Technology. He was further trained in Economy and Marketing.

  • Felix Riehn

    Felix Riehn

    Koerber Pharma Inspection

    Felix Riehn joined ‘Körber Pharma’ eight years ago and worked in the strategic marketing & Business development department in Germany and Switzerland as a Senior Analyst. Three years ago, he became Head of Product Management at ‘Körber Pharma Inspection’, formerly known as ‘Seidenader’. At the global market leader for parenteral inspection machines, he is also a product owner for Deep Learning.

  • Andrea Sardella

    Andrea Sardella, PhD

    Stevanato Group

    Andrea holds a degree in Physics from the Padua University and a master’s degree in Nuclear Engineering.

    As researcher at the National Research Council (C.N.R.) he developed several optoelectronic and nuclear scientific instruments for Magnetically Controlled Fusion Research setting up international collaboration with UWA Madison (Usa) and Garchin IPP (De).

    After 10 years of activity in research he moved to the industrial sector developing optical and vision controls for industrial application as CEO of a small-medium company. This experience drove him into the pharmaceutical field, where he started to develop several control applications with vision and spectroscopy tools. After several years he joined a leading company in this sector as R&D Manager and he developed innovative inspection technology for the inspection machines.

    Since 2008 he has been with Stevanato Group as Pharma Inspection Product Development Manager to develop new automation and inspection products dedicated to the pharmaceutical customers of the group.

  • Herve Soukiassian

    Hervé Soukiassian

    BD

    Hervé Soukiassian joined BD-Pharmaceutical Systems business 15 years ago and is currently the leader for Product Development pertaining to Prefillables Syringes for Chronic therapeutic segment. He has also contributed actively within the PDA – co-author of the TR85 “Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers” and the TR73 “Prefilled Syringe User Requirements for Biotechnology Applications”.

    Prior to joining BD, Herve worked for 13 years at Hewlett Packard in various positions gaining experience and developing expertise in the field of process engineering and product development. He later joined the board of Directors of ActiCM, a start-up company associated with the “Commissariat a l’Energie Atomique (CEA)” and specialized in optical Coordinate Measurement Machines.

    Herve graduated from the "Institut National des Sciences Appliquées" of Lyon as a mechanical & industrial engineer with a master’s degree in material sciences.

  • Linda Wildling

    Linda Wildling, PhD

    Takeda Pharmaceuticals International AG

    Linda Wildling did her PhD and Post-Doc research at the Institute for Biophysics at the University of Linz on the field “Cell Communication in Health and Disease”. In 2011 she joined Takeda Pharmaceuticals and worked in several positions within Takeda Site Quality and Production. She has broad experience in Pharmaceutical development, Auditing, Regulatory & CMC and Contract Manufacturing management, including leading a sterile production for lyophilized products.

    Linda is currently working in Digital within Takeda Manufacturing as the Global Portfolio Manager for Digital & Data Science Projects. To drive digital innovation, she is also leading the project AI-enabled, automated inspection of lyophilized products in sterile pharmaceutical manufacturing. She is the Co-Lead of Takeda´s Global Visual Inspection Program - Visual Inspection in Parenterals and Particles Management.

  • Jose Zanardi

    José M. Zanardi-Ocampo, PhD

    Syntegon

    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.

  • John Ayres

    John D. Ayres, MD

    Pharma Safety Solutions, LLC

    Dr. John Ayres received his undergraduate degree in chemistry from Butler University and a Doctor of Medicine degree from Indiana University School of Medicine. He completed his residency at the Indiana University Medical Center and is Board Certified in Internal Medicine. He obtained his Doctor of Jurisprudence from Indiana University-Bloomington and is admitted to practice law in both Indiana state and Federal courts.

    For 15 years, Dr. Ayres 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 issues related to the clinical implications of product quality attributes and variability surrounding CQAs with biopharmaceuticals in addition to safety-related compliance matters. He currently serves on the USP Visual Inspection Expert Panel and PDA’s Scientific Advisory Board.

  • Stefano Baila

    Stefano Baila, PhD

    Anemocyte

    Stefano Baila received his PhD in 2007 based upon translational research and development of gene therapies for hemophilia at the Children’s Hospital of Philadelphia. Since that time, he has been actively involved in the process development and manufacturing of advanced therapeutic medicinal products through business development and strategic marketing roles at Areta International, a CDMO, and by leading field implementation and commercialization activities for the cell processing unit of Terumo BCT.

    Stefano also worked as Industrialization Manager at Celyad where he led process development and automation efforts for CAR-T. Now he serves as Director of Operation and Business Development for Anemocyte.

  • Corey Bishop

    Corey Bishop

    Amgen

    Corey is a Senior Engineer working for Amgen Process Development, specialising in the inspection area with five years’ experience on multiple AVI vision systems which include Syntegon and Seidenader. Over the last two years he has focused on characterising and qualifying multiple lyophilized products on the Brevetti K32 and is currently the site SME at Amgen Ireland for this system. Corey holds a Bachelor’s Degree in Mechanical Engineering.

  • Antonio Burazer

    Antonio Burazer

    Takeda

    Antonio Burazer joined Takeda in 2010 and has overseen visual inspection and secondary packaging processes at a multi-product manufacturing facility in Vienna, Austria. In 2019 he transitioned to Global Manufacturing Sciences Quality, taking over responsibility for Visual Inspection and Particle Management globally for Takeda. He is striving for continuous improvement, guided by the ultimate goal to achieve zero particles in parenteral products.

  • Subrata Chakraborty

    Subrata Chakraborty, M. Sc.

    GxPFONT Consulting Group

    Subrata Chakraborty has been associated with pharmaceutical industry for over 25yrs, handling Manufacturing, Quality operations, Validations, cGMP-compliance, Training and Project management with over ten years in senior leadership roles at global MNCs ike Pfizer, Novartis, Fresenius-Kabi & Cipla.

    Subrata is currently leading GxPFONT CONSULTING GROUP, a global Pharma Consulting and Technology solutions company, as Principal Advisor.

    He is an active member of PDA and ISPE, and currently volunteers as “PDA-letter editorial committee” from Asia-pacific region. He has authored/co-authored in several technical articles and journals, and has been a regular speaker on topics related to Aseptic processing and Emerging technologies, and contributed in many industry-wide forums.

  • 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.

  • Rupert Depner

    Rupert Depner

    Körber Pharma Inspection GmbH

    Mr. Depner visited the University of Applied Science in Kempten and graduated in 2010 as Dipl.-Ing. FH (economic engineering). 2010 he started as a project engineer at Seidenader Maschinenbau GmbH. From 2012 to 2016 he was responsible as a project manager at Seidenader Maschinenbau GmbH for various projects in the field of semi- and fully automated inspection machines around the globe. 2017 he moved into the sales team and as an area sales manager for inspection machines at Körber Pharma Inspection GmbH (formerly Seidenader) he is now responsible for the sales areas Germany, Russia, and a global sales key account.

  • Massimo Frasson

    Massimo Frasson, MS

    Brevetti C.E.A. Spa

    After achieving a Master’s 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 began 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 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 C.E.A. Company.

  • Veronica Ghidotti

    Veronica Ghidotti

    Stevanato Group

    After graduating from the University of Pavia in 2003 in Computer Science focused on BioEngineering, Veronica specialized in industrial automation and processes in food and automotive industries, understanding peculiarities and challenges of high demanding processes.

    She then moved to the pharmaceutical industry and gained extensive expertise, managing serialization and smart data management projects for an important player in the market. She joined Stevanato Group in 2021 with the role of Product Manager and is responsible for the visual inspection systems portfolio management.

  • Amy Gobel

    Amy Gobel

    Johnson & Johnson

    Amy Gobel is currently serving as OI Innovation Manager in Janssen Supply Chain Schaffhausen, a pharmaceutical company of Johnson and Johnson. In this role, she is responsible for developing and implementing innovative solutions to improve material handling and inspection of parenteral products, as well as driving continuous improvements in existing technologies on site.

    After receiving a B.A. in Geosciences from Princeton University, Amy began her career in environmental consulting with a focus on evaluation and remediation of hazardous waste sites. She joined an operations-focused graduate program at the Massachusetts Institute of Technology, graduating in 2017 with an MBA and an MS in Engineering Systems.

    Amy then joined J&J Vision in the U.S. as a project manager for strategic initiatives in supply chain for contact lenses and intra-ocular lenses. Relocating to Ireland, in mid-2019, Amy became the team lead for operations services during the qualification of a combination products manufacturing facility and the launch of the first-ever drug-containing contact lens. She began her current role in January 2021.

  • Al Goodwin

    Al Goodwin

    Amgen, Inc.

    Al Goodwin has worked in the Machine Vision and Visual Inspection arena for the last 25 years.

    The last 15 years he has focused on Visual inspection systems for the Biotech and Pharma industries. At present he works in the Amgen ATA (Advanced Technology & Automation) group based in California. One key focus of this group is enhanced Visual Inspection techniques to improve the efficiency of AVI systems. Other key development areas are R & D into new viable inspection methods. He regularly gives presentations at the various industry knowledge forums and has initiated multiple patents directly related to Inspection of syringe and vial containers. Al is married with three grown up children and tries hard to expand his interests outside the machine vision field with limited success.

  • Bram Keymolen

    Bram Keymolen

    Eye-Tec

    Bram Keymolen gaduated pharmacist at the university of Antwerp and he obtained a second master degree in Industrial Pharmacy in 1999.

    Over twenty years of GMP experience in different roles, initially mainly in qualification and validation, evolving into several QA and QP positions in mainly biotech companies – both startups and corporate structures.

    After taking a position as Process Engineer in the field of visual inspection in 2006, he created his own consultancy company in this domain in 2011. Eye-Tec supports visual inspection and CCIT projects under GMP. Missions vary from CAPA-development to major CAPEX projects or corporate strategy development for visual inspection and CCIT. Eye-Tec offers both technical solutions (vision tuning and optical/mechanical improvement) and compliance support to customers worldwide.

  • Robert Miller

    Robert J. Miller

    Pfizer Inc.

    Rob Miller leads a team of visual inspection subject matter experts that support Pfizer Global Supply (PGS) sterile injectables network. This support includes compliance related guidance for particle, MVI and AVI topics based on the latest guidance and requirements. In addition, they also provide direction for the adoption of new technology or using proven methods that still provide robust 100% visual inspection.

    Prior to this role, Rob Miller worked for Pfizer Global Quality as a subject matter expert in visual inspection. He was responsible for supporting Pfizer’s aseptic network with internal quality standards and policy related to manual and automated visual inspection. Rob has a B.S. in Electrical Engineering, an M.S. in Engineering Management, and a Graduate Certificate in Applied Statistics.

  • Daniel Mueller

    Daniel Mueller, PhD

    German GMP Inspectorate

    Mr. Daniel Mueller studied Pharmacy at the University of Wuerzburg, Germany, followed by his doctorate. He started working in the pharmaceutical industry in 1998. Previously he served as a qualified person for sterile products (large volume parenterals) and in 2001 he joined a German GMP Inspectorate at Tuebingen, Baden-Wuerttemberg. Since then, he has been working as a GMDP-Inspector with focus on biotechnological active pharmaceutical ingredients and sterile drug products. Currently, he is the head of the GMP Inspectorate at Tuebingen. Additionally, Mr. Mueller is a member of the German Expert Groups "Biotechnology and Tissue" and "Quality Assurance". He has got further qualification in pharmaceutical analytics and public health management.

  • Heino Prinz

    Heino Prinz, PhD

    Rommelag

    Heino holds a degree in Physical Chemistry from the University of Ulm and a PhD with a focus on infrared laser spectroscopy.

    He has worked as a researcher in France, Austria, U.S., and Australia. Since 1995, he is a member of the Chamber of Commerce in Ulm as Technology Consultant. In 1997, he joined Uhlmann Pac-Systeme GmbH & Co. KG in Laupheim, responsible for the introduction of NIR-Spectroscopy into the packaging process. He was a co-founder of Uhlmann VisioTec GmbH in 2000 where he became Head of R&D. He expanded the R&D department towards PAT and Consulting. In August 2010, he joined Wilco AG, in charge of research and development. In February 2014, he moved on to Kocher-Plastik Maschinenbau GmbH as director of the department of inspection devices.

    His profound knowledge of the pharmaceutical industry and his expertise in X-Ray Inspection, Vision Technology and Spectroscopy helped the companies to develop high-speed inspection systems, which are used in numerous applications in the pharmaceutical manufacturing process. Heino also develops specifications for existing processes and provides consulting for pharmaceutical clients to achieve goals like Six Sigma processing, Right First Time Manufacturing, and Quality by Design standards, in conjunction with the technological developments are under his responsibility.

  • Jan Sende

    Jan Sende

    Syntegon

    Jan A. Sende studied physics at the Friedrich-Schiller Universität Jena. After obtaining his Master’s degree in 2015 he worked additional 5 years in the field of astrophysics, writing high-performance simulations in C++. Since joining Syntegon Japan in 2020, Jan was assigned as a vision engineer to customer projects where he develops solutions for optimal imaging and inspection of difficult to inspect products.

  • Erika Stippler

    Erika Stippler, PhD

    EDQM

    Erika Stippler, Ph.D. is the Scientific Program Manager at the European Pharmacopeia division of the EDQM in Strasbourg, France. She joined EDQM in 2019 after having worked at the United States Pharmacopeia in Rockville, Maryland, U.S.  for more than 12 years. Erika began her career in the pharmaceutical industry as a manufacturing associate in the manufacturing of injectables at Therapia in Cluj-Napoca, Romania. Later, she worked as a scientist at the Central Laboratory of German Pharmacists (ZL) in Eschobrn, Germany. While working in ZL she proceeded to attend the W. J. Goethe University Frankfurt Institute of Pharmaceutical Technology as an external Ph.D. student. She received her Ph.D.in 2004 in pharmaceutical technology under the guidance of Prof. Jennifer B. Dressman.

    Erika continued her professional career as head of Biopharmacy/Stability Testing of Laboratory and Quality Services (LQS) in Eschborn, Germany and later as Technical Director of PHAST in Homburg, Germany. Before moving to the United States in 2007, she worked for a short time as Project Manager at Solvias AG, Basel, Switzerland.

  • 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 25 years of experience in the pharmaceutical and semiconductor industries, including the last 12 years at Merck focusing on the visual inspection processes for parenteral products. Currently, Joe works in global technical operations where he provides support for vision inspection processes and primary packaging components to Merck’s manufacturing sites and partners around the world.

  • Denise Tellbach

    Denise Tellbach

    Massachusetts Institute of Technology

    Denise Tellbach is a graduate student in Mechanical Engineering at MIT. Her research interests are in IoT, sensing, and applying machine learning to enhance the functionality of industrial quality control. Denise received a double master’s degree in Management Science and Mechanical Engineering from RWTH Aachen University and Tsinghua University in 2018 and her undergraduate degree from RWTH Aachen University in 2016. In the past she has developed a maturity model for the digitalization of production control, she has worked on cyber-physical systems modelling and on reliability assessment focusing on the electric grid. She joined the AutoID Lab as a graduate student under Prof. Sarma in 2019 and is a Presidential Fellow at MIT (2019).