PDA Visual Inspection Forum 2025

Continental Breakfast

Registration Open

P1: Regulatory Perspectives

• Moderator: Rick J. Watson, BS Chem Eng, Director, Merck

  

  Rick J. Watson, BS Chem Eng, Director, Merck
  

  Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 28 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 twenty 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 glass breakage management for Merck manufacturing sites around the world.

• 08:30 – 08:45

  Welcome and Opening Remarks from Forum Co-Chairs

  • Co-Chair: Romain Veillon, Director Vision Technology, GSK

    

    Romain Veillon, Director Vision Technology, GSK
    

    Already done

  • Co-Chair: Rick J. Watson, BS Chem Eng, Director, Merck

    

    Rick J. Watson, BS Chem Eng, Director, Merck
    

    Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 28 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 twenty 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 glass breakage management for Merck manufacturing sites around the world.

• 08:45 – 09:15

  Visual Inspection Regulatory and Compendial Update

  • Presenter: John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    

    John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
    

    John is the founder of Insight Pharma Consulting, providing expert guidance in visual inspection and particle control. He began his career with The Upjohn Company responsible for process analytical technology (PAT) and visual inspection. He was Director of Technical Support and Engineering for Pharmacia with responsibility for sterile and non-sterile technology transfer and process improvement, package engineering and automation. He later served as Director of the Center for Advanced Sterile Technology. Before starting his consulting firm, he managed microbiology and aseptic manufacturing technical support for Pfizer’s Global Quality Operations. 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, having served as chair of the Board of Directors and chair of the Science Advisory Board. He organized and co-leads the Visual Inspection Interest Group. He also instructs 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 has published and presented numerous papers on spectroscopic analysis, PAT, rapid microbiological testing and visual inspection of pharmaceutical products. He co-authored the recently published book Visual Inspection and Particulate Control.

• 09:15 – 09:45

  Regulatory Expectations for the Assessment of Visible Particulates in Injectable Pharmaceuticals

  • Presenter: Rukman S De Silva, Policy Lead, OPQ, CDER, U.S. FDA

    

    Rukman S De Silva, Policy Lead, OPQ, CDER, 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 FDA/CDER/OPQ/Office of Biotechnology Products (OBP). At OBP, he conducted chemistry manufacturing and controls (CMC) review and inspectional activities related to biological product applications submitted to the FDA. In 2022, he joined FDA/CDER/OPQ/OPPQ/DIPAC, Branch II. Rukman’s current responsibilities include the development of FDA policies and programs pertaining to pharmaceutical quality

• 09:45 – 10:15

  Q&A

Networking Break in the Exhibit Hall

Poster Presentations in the Exhibit Hall

P2: Process Development

• Moderator: Romain Veillon, Director Vision Technology, GSK

  

  Romain Veillon, Director Vision Technology, GSK
  

  Already done

• 11:00 – 11:30

  Visual Inspection Challenges in Gene and Cell Therapy Production: From Clear Glass and Product to Opaque Plastic and Product

  • Presenter: Ines Bauer, Expert Science & Technology, Novartis Pharmaceutical Manufacturing GmbH, Schaftenau

    

    Ines Bauer, Expert Science & Technology, Novartis Pharmaceutical Manufacturing GmbH, Schaftenau
    

    Ines Bauer holds a master’s degree in botany, a bachelor’s degree in biology and has an academic background in zoology. Since joining Sandoz/Novartis in 2015, she has been an integral part of the pilot plant, drug product development Schaftenau, where she focuses on visual inspection processes and has developed extensive expertise in test set creation. Over the years, her attention to detail and knowledge in these areas have significantly contributed to the success of numerous projects.

• 11:30 – 12:00

  How to Boost Your Manual Visual Inspection: A Case Study of Improving the Efficiency of MVI

  • Presenter: Antonio Burazer, Global Head Visual Inspection & Particle LCM, Takeda

    

    Antonio Burazer, Global Head Visual Inspection & Particle LCM, Takeda
    

    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 global responsibility for visual inspection and particle life cycle management for Takeda and leading the harmonization and improvement program across 15 internal sites and 13 CMOs. He is engaged in collaborating with experts across the industry and strives for continuous improvement, guided by the ultimate goal to achieve zero particles in parenteral products.

Networking Lunch with Exhibitors

Interactive Questionnaire Session

A1: New challenges in Visual Inspection Qualification

• Moderator: Andrea Sardella, PhD

  

  Andrea Sardella, PhD
  

  Andrea Sardella holds a degree in Physics from Padua University and a Master's in Nuclear Engineering. As a researcher at the National Research Council (C.N.R.), he developed several optoelectronic and nuclear scientific instruments for Magnetically Controlled Fusion Research. He also set up international collaborations with UWA Madison (USA) and Garching IPP (DE). After ten years of activity in research, he moved to the industrial sector to develop optical and vision controls for industrial applications 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. He then joined a leading company as R&D Manager, for which he developed an innovative inspection technology for inspection machines. Since 2008 he has been with Stevanato Group first as Pharma Inspection Product Development Manager. Here, he works to develop new automation and inspection products dedicated to the pharmaceutical customers of the Group.

• 13:45 – 14:05

  Successful Qualification of an AI-Model for a Low-Fill Liquid Vial Particle Inspection

  • Presenter: Bastian Kronenbitter, Head of Data Science, Körber Pharma Inspection GmbH

    

    Bastian Kronenbitter, Head of Data Science, Körber Pharma Inspection GmbH
    

    Bastian Kronenbitter is the Head of Data Science at InspectifAI, where he has led the team since April 2022. He holds a PhD in Physics from the Karlsruhe Institute of Technology (KIT), where he focused on high-energy particle physics experiments, particularly at the Belle detector. His academic background includes significant contributions to the study of CP violation, branching fractions, and B-meson decays. His work has been published in leading physics journals, including Physical Review D, and presented at international conferences such as ICHEP and PANIC. Before joining InspectifAI, Bastian held data science leadership roles at Körber Digital and Adello. He combines his expertise in data science and physics with a deep understanding of team leadership and complex systems analysis.

  • Co-Presenter: Bastian Kronenbitter, Head of Data Science, Körber Pharma Inspection GmbH

    

    Bastian Kronenbitter, Head of Data Science, Körber Pharma Inspection GmbH
    

    Bastian Kronenbitter is the Head of Data Science at InspectifAI, where he has led the team since April 2022. He holds a PhD in Physics from the Karlsruhe Institute of Technology (KIT), where he focused on high-energy particle physics experiments, particularly at the Belle detector. His academic background includes significant contributions to the study of CP violation, branching fractions, and B-meson decays. His work has been published in leading physics journals, including Physical Review D, and presented at international conferences such as ICHEP and PANIC. Before joining InspectifAI, Bastian held data science leadership roles at Körber Digital and Adello. He combines his expertise in data science and physics with a deep understanding of team leadership and complex systems analysis.

• 14:05 – 14:25

  Qualifying an Automated Visual Inspection (AVI) Using Recirculation Function

  • Presenter: Jun L. Ordonez, Sr. Manager, Pfizer

    

    Jun L. Ordonez, Sr. Manager, Pfizer
    

    Jun Ordonez Sr. Manager - Pfizer Gene Therapy Technical Services Drug Substance/Product – Sanford NC  Direct and manage Technical Services for Gene Therapy DS/DP team performing scientific, operational and process engineering tasks related to technology transfer and routine manufacturing support.  Lead in the execution optimization, implementation, troubleshooting, tracking, and reporting of a variety manufacturing processes for clinical and commercial production of gene therapy programs. Manager 2016-2021 - Pfizer Global Technology and Engineering (GT&E) – Visual Inspection SME  Served as scientific and technical representative for process-related Visual Inspection (VI) issues within Pfizer network.  Manage Implementation of Visual Inspection Technical Transfer to CMOs  Provide sound rationale on Automated Visual Inspection (AVI) Capital requirements to obtain necessary project approval on high-cost projects and oversee multiple high capital projects that are critical to site/s operations.  Provide strategies to ensure that VI programs are robust and defendable on audits and provide regulatory audit support.  Provide trouble shooting, root cause analysis serving as scientific and technical expert on issues that affect AVI.  Provide technical support on CMOs Visual Inspection program.  Conduct assessments to multiple sites Visual Inspection Program  Co-Represent Pfizer on multi-pharmaceutical industry SMEs network (BioPhorum)

• 14:25 – 14:45

  Development of a Global Standard Operating Procedure Across the Manufacturing Network for Both Liquid and Difficult to Inspect Parenterals Case Study

  • Presenter: Pere Joaquin, Director of Site Quality and QP, Reig Jofre

    

    Pere Joaquin, Director of Site Quality and QP, Reig Jofre
    

    Degree in pharmacy, MSc in pharmaceutical industry and postgraduate in clinical nutrition. Experience in Regulatory Affairs and Pharmacovigilance. Experience in aseptic manufacturing and Quality Assurance at B.Braun Spain (Barcelona area) manufacturing site for more than 7 years. Joined Labiana Pharmaceuticals as Deputy QP and subsequently Quality Unit Director and main Qualified Person of a sterile and aseptic manufacturing site (freeze dried, aseptic, sterile, both ampoules and vials, sterile eye drops), also solid and liquid oral forms. Followed by Neuraxpharm manufacturing site (sterile eye drops and solid oral forms) as Quality Unit Director and QP of the site for almost a year. Most recent role, I joined Laboratorio Reig Jofre in Barcelona and I performed my actual role as Quality Unit Director and main QP of this sterile and aseptic manufacturing site (freeze dried and liquid aseptic and sterile vials and liquid ampoules), also solid and liquid oral forms and topical forms for more than 3 years up to date.

• 14:45 – 15:15

  Q&A

B1: Advances in Particle Investigations

• Moderator: Robert J Miller, Director, Technical Services, Pfizer Inc

  

  Robert J Miller, Director, Technical Services, Pfizer Inc
  

  TBD

• 13:45 – 14:05

  Problem Solving During Trace Foreign Matter Investigations: Points to Consider

  • Presenter: Mary Lee Ciolkowski, PhD, Sr. Principal Scientist, Bausch + Lomb

    

    Mary Lee Ciolkowski, PhD, Sr. Principal Scientist, Bausch + Lomb
    

    Mary Lee Ciolkowski is a Sr. Principal Scientist at Bausch + Lomb and has 20+ years of experience spanning R&D through product launch and on-going manufacturing support. Mary Lee is an SME in the characterization of sub-visible and visible particles in pharmaceutical dosage forms during development and drug product quality control/stability studies. This includes support of particle-related root-cause analyses and investigations at US and global manufacturing sites. Mary Lee also supports visual inspection training and ensuring compliant visual inspection systems are implemented at manufacturing sites. Mary Lee is a member of the USP1790 and USP788 Expert Panels.

• 14:05 – 14:25

  Achieving Particle Reduction via Supplier Contamination Control Strategies and Innovation in RTF Packaging

  • Presenter: Colleen O'Brien, MS, Strategy and Technical Affairs, Gerresheimer

    

    Colleen O'Brien, MS, Strategy and Technical Affairs, Gerresheimer
    

    Colleen O'Brien has more than 20yrs of experience in pharmaceutical manufacturing and primary packaging as a subject matter expert for fill finish of injectable drugs. She holds a BS in Biochemistry from Albright College, a MS in Manufacturing Systems Engineering from Lehigh University, and is currently an MBA candidate at Lehigh University. She has held various roles including Senior Aseptic Operator,Technology Transfer Engineer, Validation Specialist, and Business Development Manager. Her previous companies include sanofi pasteur, Merck, Jubilant HollisterStier, Schott, and Gerresheimer.

• 14:25 – 14:45

  Cellulose - Understanding and Narrowing Down its Sources

  • Presenter: Casey M Jarvis, Research Scientist, MVA Scientific Consultants

    

    Casey M Jarvis, Research Scientist, MVA Scientific Consultants
    

    Casey is the lead expert at MVA Scientific Consultants for pharmaceutical and biomedical testing. She is one of MVA’s executive directors and project leaders, bridging communication between the client and the scientist. Casey is a chemist with experience in particle isolation and characterization, material analysis, and investigative analysis. She works with a variety of microscopes and complementary techniques to provide comprehensive results and supporting data. Fourier transform infrared spectroscopy (FTIR) and confocal Raman microscopy (CRM) are Casey’s specialties. Casey commits to quality through technical review and as deputy of MVA’s quality team.

• 14:45 – 15:15

  Q&A

Networking Break in the Exhibit Hall

Poster Presentations in the Exhibit Hall

A2: Particle Detection Capability

• Moderator: Rukman S De Silva, Policy Lead, OPQ, CDER, U.S. FDA

  

  Rukman S De Silva, Policy Lead, OPQ, CDER, 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 FDA/CDER/OPQ/Office of Biotechnology Products (OBP). At OBP, he conducted chemistry manufacturing and controls (CMC) review and inspectional activities related to biological product applications submitted to the FDA. In 2022, he joined FDA/CDER/OPQ/OPPQ/DIPAC, Branch II. Rukman’s current responsibilities include the development of FDA policies and programs pertaining to pharmaceutical quality

• 16:00 – 16:20

  Beyond Size and Shape: The Role of Color in Particle Detection

  • Presenter: Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG

    

    Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG
    

    Atanas Koulov has extensive experience in pharmaceutical drug product development and manufacturing from Roche/Genentech, Novartis and Lonza. His focus areas are drug product control strategies, particle contamination and quality control. He has authored more than 50 scientific publications and book chapters. He is a co-founder and Chief Scientific Officer or Clear Solutions Laboratories AG.

• 16:20 – 16:40

  3D Printed Protein-Like Model Particles as Particle Standards for Performance Evaluation of Novel Human-Inspired Automated Visual Inspection Instrument

  • Presenter: Oliver Germershaus, Professor, University of Applied Sciences Northwestern Switzerland

    

    Oliver Germershaus, Professor, University of Applied Sciences Northwestern Switzerland
    

    Oliver Germershaus is Professor of Pharmaceutics of Macromolecular Drugs at University of Applied Sciences Northwestern Switzerland focussing on research and development in the field of biologics formulation and processing, drug delivery system development and parenteral packaging and device development. In recent years special emphasis was on development of novel particle standards, specifically designed to match the appearance and behaviour of protein particles. Furthermore, evaluation of container-closure integrity, especially at frozen and cryogenic storage conditions is a current focus topic.

• 16:40 – 17:00

  Case Studies: Increasing PoD in MVI for DIP

  • Co-Presenter: Menno Sels, MSE, Project Engineer VI & CCIT, eyetec

    

    Menno Sels, MSE, Project Engineer VI & CCIT, eyetec
    

    Graduated Chemical Engineer involved in several GMP projects in the past 5 years. First hand experience in managing Visual Inspection projects from A to Z. Determined problem-solver and analytical thinker.

  • Presenter: Bram J.J. KEYMOLEN, Co-Founder, eyetec

    

    Bram J.J. KEYMOLEN, Co-Founder, eyetec
    

    Graduated pharmacist at the university of Antwerp, Bram Keymolen 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, 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.

• 17:00 – 17:30

  Q&A

B2: Novel AI-Based Equipment for Difficult-to-Inspect Products

• Moderator: Linda Wildling, PhD, Head of Digital Innovation Success Management, Takeda Pharmaceuticals International AG

  

  Linda Wildling, PhD, Head of Digital Innovation Success Management, Takeda Pharmaceuticals International AG
  

  Linda Wildling did her Ph.D. and Post-Doc research at the Institute for Biophysics at the University of Linz in Cell Communication in the Health and Disease field. 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 sterile production and lyophilized products. Linda works in Digital within Takeda Manufacturing as Head of Digital Innovation Success Management. 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.

• 16:00 – 16:20

  Difference Between Rule-Based and AI Algorithms in the Quality Control of Difficult-to-Inspect Parenterals

  • Presenter: Matthias Kahl, Head of R&D and Lab Services, WILCO AG

    

    Matthias Kahl, Head of R&D and Lab Services, WILCO AG
    

    Dr. Matthias Kahl has been Head of the Research, Development and Laboratory Services of WILCO AG in Wohlen since 2018. He started in 2017 as responsible for development of new technologies. After studying physics at the University of Erlangen in the field of solid state physics and physical metrology, he obtained his doctorate in modern optics and laser technology at the University of Konstanz in 2006. This was followed by a position as deputy development manager in the field of high-precision material processing with lasers. Further tasks include innovation management, intellectual property issues, and collaboration in quality management.

• 16:20 – 16:40

  Enhancing Image Classification and Reducing False Rejection Rates in BFS DIP Products Using AI on AVI systems

  • Presenter: GIANMARCO PINCELLI, Technical Sales Manager, Bonfiglioli Engineering srl

    

    GIANMARCO PINCELLI, Technical Sales Manager, Bonfiglioli Engineering srl
    

    Gianmarco Pincelli is currently in charge as Technical Sales Manager at Bonfiglioli Engineering, which is part of TASITEST Group. He received its degree in Mechanical and Specialization on Machinery Technical Documentation in Ferrara (Italy) in 1998, and after some work experiences as a freelance for different Mechanical Design Offices, in 1999 he joined Bonfiglioli Engineering. Devoting his professional life, at the beginning as Mechanical Designer Pharma Specialist and shifted progressively to Pharmaceutical Application Team Leader and to Design Team Manager in 2010 till 2019. Now he moved to the Sales, being responsible for Sales Network & worldwide agencies technical training, and giving assistance in customized projects; he also represents BE company at PDA events as well as other congresses and exhibitions.

• 16:40 – 17:00

  Unsupervised Machine Learning Applied to Difficult-to-Inspect Products

  • Presenter: Brian Turnquist, PhD, Chief Technical Officer, Boon Logic

    

    Brian Turnquist, PhD, Chief Technical Officer, Boon Logic
    

    Brian Turnquist is Chief Technical Officer of Boon Logic, an AI software company in Minneapolis specializing in applying unsupervised machine learning in regulated industries and mission critical applications. Turnquist received his PhD in mathematics from the University of Maryland in 1997 and spent most of his career in neuroscience developing techniques for automated classification of neural activity, with full-time positions at Johns Hopkins University, Bethel University, and visiting research appointments at the Universities of Nürnberg and Heidelberg. At Boon Logic, Turnquist has applied these techniques to computer vision-based anomaly detection, leading to the development of novel, AI-based technologies for visual inspection of parenterals.

• 17:00 – 17:30

  Q&A

Networking Reception in Exhibit Hall

Continental Breakfast

Registration Open

P3: Visual Inspection Acceptance Sampling and Performance Measurement

• Moderator: John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

  

  John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
  

  John is the founder of Insight Pharma Consulting, providing expert guidance in visual inspection and particle control. He began his career with The Upjohn Company responsible for process analytical technology (PAT) and visual inspection. He was Director of Technical Support and Engineering for Pharmacia with responsibility for sterile and non-sterile technology transfer and process improvement, package engineering and automation. He later served as Director of the Center for Advanced Sterile Technology. Before starting his consulting firm, he managed microbiology and aseptic manufacturing technical support for Pfizer’s Global Quality Operations. 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, having served as chair of the Board of Directors and chair of the Science Advisory Board. He organized and co-leads the Visual Inspection Interest Group. He also instructs 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 has published and presented numerous papers on spectroscopic analysis, PAT, rapid microbiological testing and visual inspection of pharmaceutical products. He co-authored the recently published book Visual Inspection and Particulate Control.

• 08:30 – 09:00

  Sampling in the Visual Inspection Process: AQL and Defect Trending

  • Presenter: Robert J Miller, Director, Technical Services, Pfizer Inc

    

    Robert J Miller, Director, Technical Services, Pfizer Inc
    

    TBD

• 09:00 – 09:30

  Use of Mathematical Model for Detection Performances Comparison of MVI versus AVI

  • Presenter: Mitsutaka Shirasaki, Principal Engineer, Genentech Inc.

    

    Mitsutaka Shirasaki, Principal Engineer, Genentech Inc.
    

    Mitsutaka Shirasaki is a Principal Engineer at Genentech/Roche with 24 years of experience in the visual inspection field. His career started with Eisai Machinery (currently Syntegon Pharmaceutical Technology) as a field service Engineer and worked with many companies in the industry for qualification of AVI equipment. He is a member of the BioPhorum VI workstream and published multiple industry guidance papers along with other esteemed authors. He is passionate about advancing the VI technologies and developing more effective methods of AVI qualification.

• 09:30 – 10:00

  Q&A

Networking Break in the Exhibit Hall

Poster Presentations in the Exhibit Hall

A3: Inspection Optimization

• Moderator: Markus Adlberger, MSc, Product Owner Visual Inspection Software, Körber Pharma

  

  Markus Adlberger, MSc, Product Owner Visual Inspection Software, Körber Pharma
  

  Markus Adlberger is the Product Owner for Visual Inspection Software at Körber Pharma Inspection in Markt Schwaben, Germany. He has over 15 years of experience in the visual inspection of pharmaceutical products, both within Körber Pharma Inspection and the pharmaceutical industry. In his current role, he is responsible for the ongoing development of the Visual Inspection Software and manages the requirements from external and internal customers, ensuring continuous innovation and maintaining high standards in pharmaceutical visual inspection.

• 10:45 – 11:05

  Modernization of an MVI Program to Improve Defect Detection

  • Presenter: David B Wetherington, Sr. Manager, Operations (Visual Inspection and Packaging), Thermo Fisher Scientific

    

    David B Wetherington, Sr. Manager, Operations (Visual Inspection and Packaging), Thermo Fisher Scientific
    

    Blaine Wetherington Senior Manager of Operations (inspection and Packaging) at Patheon, a part of Thermo Fisher Scientific) 17 years of pharmaceutical industry experience spanning multiple roles and responsibilities including industrial engineering, continuous improvement and operations.

• 11:05 – 11:25

  Revolutionizing Pharmaceutical Inspection: Upgrading to Automated Visual Inspection Systems

  • Presenter: Scott Council, North Carolina Division Director, Performance Validation

    

    Scott Council, North Carolina Division Director, Performance Validation
    

    Scott is a senior leader with 20+ years of progressive operations leadership, including 20 years in the biomedical/pharmaceutical industry. Leverages strong drive for customer satisfaction, building of high performing teams, analytical decision-making perspective, excellent communication, and diverse problem-solving skills to accomplish business goals and propel technical innovation.

  • Co-Presenter: Bill Waterstreet, Principal Validation Engineer, Performance Validation

    

    Bill Waterstreet, Principal Validation Engineer, Performance Validation
    

    Bill has supported cGMP compliance projects for the pharmaceutical industry since 2015. Has experience in the development of validation documentation and specifications for equipment including the associated control systems. Has also supported building commissioning for both new construction and building renovations. Experience includes facilities, clean utilities, dirty utilities, HVACR, and inspection equipment.

• 11:25 – 11:45

  Manual Visual Inspection (MVI) and Inspector Training and Qualification

  • Presenter: Tracey Sinjen, Principal Consultant, Lachman Consultants

    

    Tracey Sinjen, Principal Consultant, Lachman Consultants
    

    tbd

• 11:45 – 12:15

  Q&A

B3: Novel Inspection Equipment Design and Application

• Moderator: Rick J. Watson, BS Chem Eng, Director, Merck

  

  Rick J. Watson, BS Chem Eng, Director, Merck
  

  Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 28 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 twenty 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 glass breakage management for Merck manufacturing sites around the world.

• 10:45 – 11:05

  AI-Driven Visual Inspection: Unlocking Data for Smarter Production

  • Presenter: Massimo Frasson, Ceo & General Manager, BREVETTI C.E.A. S.p.A.

    

    Massimo Frasson, Ceo & General Manager, BREVETTI C.E.A. S.p.A.
    

    Mr. Massimo Frasson holds a Master's Degree in Mechanical Engineering and has a successful career in the automation industry. He began his journey with Brevetti C.E.A. in 2000 as the Mechanic Systems Design Manager and progressively assumed more significant roles. In 2007, he played a pivotal role in Brevetti C.E.A.'s restructuring and the introduction of new vision technologies. Simultaneously, he led a department focused on pharmaceutical process analysis using artificial vision systems and neural algorithms. In 2010, Mr. Massimo Frasson took on the responsibility for the entire operations process and was appointed General Manager in February 2014. His leadership and dedication led to his promotion to CEO in 2019. Today, he continues to drive Brevetti C.E.A.'s growth and development with his extensive industry knowledge and commitment to excellence.

• 11:05 – 11:25

  A Semi-Automated IV Bag Inspection System (IVBIS)

  • Presenter: Neil Jesse Hamilton, Vice President Technical Services, AWS Bio-Pharma Technologies LLC

    

    Neil Jesse Hamilton, Vice President Technical Services, AWS Bio-Pharma Technologies LLC
    

    Please join AWS in welcoming Neil Hamilton as Vice President of Technical Services. Neil is a veteran of the United States Air Force where he received an honorable discharge. He has many years of experience as a project engineer for CAD design and test engineering. Much of his project work was heavily involved with R&D and innovation management. His background includes aircraft mechanical work, aerospace gunfire testing, spacecraft systems design, design of new construction products and fire testing of construction products. Neil has also worked in the pharmaceutical industry as a QA lab engineer where he used Good Manufacturing Practices and Good Documentation Practices while commissioning new laboratory equipment. While at AWS Bio-Pharma Neil has designed components of the IVBIS (IV Bag Inspection System), performed fluid mechanics calculations for a WFI loop, checked drawings, built modular cleanrooms, and other hands on and engineering tasks. He also sourced the camera and video system for the IVBIS system. Additionally, he has assisted as an inside sales professional doing cold calling and writing quotes.

• 11:25 – 11:45

  The Next Phase in Visual Inspection – Complete Electronic Records

  • Presenter: Gerlad Budd, President, Phoenix Imaging Ltd.

    

    Gerlad Budd, President, Phoenix Imaging Ltd.
    

    Holds BS in Physics & Chemistry (principal area of study Optics), MS in Quality Systems. Founder of Phoenix Imaging companies in 1985 with multiple patents in manual and automated inspection systems. Over 40 years' experience in machine vision technology specializing in high resolution 3-D measurements. Design and manufacture of Manual Inspection Booths since 1999.

• 11:45 – 12:15

  Q&A

Networking Lunch with Exhibitors

Interactive Questionnaire Session

P4: Visual Inspection Process Development and Qualification

• Moderator: Linda Wildling, PhD, Head of Digital Innovation Success Management, Takeda Pharmaceuticals International AG

  

  Linda Wildling, PhD, Head of Digital Innovation Success Management, Takeda Pharmaceuticals International AG
  

  Linda Wildling did her Ph.D. and Post-Doc research at the Institute for Biophysics at the University of Linz in Cell Communication in the Health and Disease field. 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 sterile production and lyophilized products. Linda works in Digital within Takeda Manufacturing as Head of Digital Innovation Success Management. 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.

• 13:30 – 14:00

  Visual Inspection Validation Considerations for Traditional and New Technology

  • Presenter: Rick J. Watson, BS Chem Eng, Director, Merck

    

    Rick J. Watson, BS Chem Eng, Director, Merck
    

    Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 28 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 twenty 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 glass breakage management for Merck manufacturing sites around the world.

• 14:00 – 14:30

  Benefit of Digital Visual Inspection Platform

  • Presenter: Romain Veillon, Director Vision Technology, GSK

    

    Romain Veillon, Director Vision Technology, GSK
    

    Already done

• 14:30 – 15:00

  Q&A

Networking Break in the Exhibit Hall

Poster Presentations in the Exhibit Hall

P5: Panel Discussion

• Moderator: Romain Veillon, Director Vision Technology, GSK

  

  Romain Veillon, Director Vision Technology, GSK
  

  Already done

• Moderator: Rick J. Watson, BS Chem Eng, Director, Merck

  

  Rick J. Watson, BS Chem Eng, Director, Merck
  

  Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 28 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 twenty 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 glass breakage management for Merck manufacturing sites around the world.

• 15:45 – 16:55

  Panel Discussion

  • Panelist: Markus Adlberger, MSc, Product Owner Visual Inspection Software, Körber Pharma

    

    Markus Adlberger, MSc, Product Owner Visual Inspection Software, Körber Pharma
    

    Markus Adlberger is the Product Owner for Visual Inspection Software at Körber Pharma Inspection in Markt Schwaben, Germany. He has over 15 years of experience in the visual inspection of pharmaceutical products, both within Körber Pharma Inspection and the pharmaceutical industry. In his current role, he is responsible for the ongoing development of the Visual Inspection Software and manages the requirements from external and internal customers, ensuring continuous innovation and maintaining high standards in pharmaceutical visual inspection.

  • Panelist: Rukman S De Silva, Policy Lead, OPQ, CDER, U.S. FDA

    

    Rukman S De Silva, Policy Lead, OPQ, CDER, 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 FDA/CDER/OPQ/Office of Biotechnology Products (OBP). At OBP, he conducted chemistry manufacturing and controls (CMC) review and inspectional activities related to biological product applications submitted to the FDA. In 2022, he joined FDA/CDER/OPQ/OPPQ/DIPAC, Branch II. Rukman’s current responsibilities include the development of FDA policies and programs pertaining to pharmaceutical quality

  • Panelist: Robert J Miller, Director, Technical Services, Pfizer Inc

    

    Robert J Miller, Director, Technical Services, Pfizer Inc
    

    TBD

  • Panelist: Andrea Sardella, PhD

    

    Andrea Sardella, PhD
    

    Andrea Sardella holds a degree in Physics from Padua University and a Master's in Nuclear Engineering. As a researcher at the National Research Council (C.N.R.), he developed several optoelectronic and nuclear scientific instruments for Magnetically Controlled Fusion Research. He also set up international collaborations with UWA Madison (USA) and Garching IPP (DE). After ten years of activity in research, he moved to the industrial sector to develop optical and vision controls for industrial applications 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. He then joined a leading company as R&D Manager, for which he developed an innovative inspection technology for inspection machines. Since 2008 he has been with Stevanato Group first as Pharma Inspection Product Development Manager. Here, he works to develop new automation and inspection products dedicated to the pharmaceutical customers of the Group.

  • Panelist: John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    

    John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
    

    John is the founder of Insight Pharma Consulting, providing expert guidance in visual inspection and particle control. He began his career with The Upjohn Company responsible for process analytical technology (PAT) and visual inspection. He was Director of Technical Support and Engineering for Pharmacia with responsibility for sterile and non-sterile technology transfer and process improvement, package engineering and automation. He later served as Director of the Center for Advanced Sterile Technology. Before starting his consulting firm, he managed microbiology and aseptic manufacturing technical support for Pfizer’s Global Quality Operations. 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, having served as chair of the Board of Directors and chair of the Science Advisory Board. He organized and co-leads the Visual Inspection Interest Group. He also instructs 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 has published and presented numerous papers on spectroscopic analysis, PAT, rapid microbiological testing and visual inspection of pharmaceutical products. He co-authored the recently published book Visual Inspection and Particulate Control.

  • Panelist: Romain Veillon, Director Vision Technology, GSK

    

    Romain Veillon, Director Vision Technology, GSK
    

    Already done

  • Panelist: Rick J. Watson, BS Chem Eng, Director, Merck

    

    Rick J. Watson, BS Chem Eng, Director, Merck
    

    Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 28 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 twenty 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 glass breakage management for Merck manufacturing sites around the world.

  • Panelist: Linda Wildling, PhD, Head of Digital Innovation Success Management, Takeda Pharmaceuticals International AG

    

    Linda Wildling, PhD, Head of Digital Innovation Success Management, Takeda Pharmaceuticals International AG
    

    Linda Wildling did her Ph.D. and Post-Doc research at the Institute for Biophysics at the University of Linz in Cell Communication in the Health and Disease field. 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 sterile production and lyophilized products. Linda works in Digital within Takeda Manufacturing as Head of Digital Innovation Success Management. 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.

• 16:55 – 17:00

  Closing Remarks from Forum Co-Chairs

  • Co-Chair: Romain Veillon, Director Vision Technology, GSK

    

    Romain Veillon, Director Vision Technology, GSK
    

    Already done

  • Co-Chair: Rick J. Watson, BS Chem Eng, Director, Merck

    

    Rick J. Watson, BS Chem Eng, Director, Merck
    

    Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 28 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 twenty 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 glass breakage management for Merck manufacturing sites around the world.