PDA Visual Inspection Forum 2025

EDT Daylight Time (UTC -4:00)

• 08:30 – 16:00

  Fundamentals of Automated Visual Inspection Training Course - Separate Registration Required

  • Instructor:

    

    Andrea Sardella, PhD
    Customer Success Manager, Brevetti CEA

  This training course will provide a basic understanding of the automated visual inspection (AVI) process and technology. Participants will learn how the capability of AVI process is dependent on the equipment, development and validation processes, as well as discuss the advantages and disadvantages of AVI technology. During this training course, participants will evaluate validation strategies to determine which approach to use under given circumstances. A case study will also be discussed.

  This training course is an excellent opportunity to discuss questions that you have and to interact with others who are facing and overcoming the same inspection issues.

  Training Course Information and Registration

• 08:30 – 16:00

  Identification and Classification of Nonconformities in Glass Containers Training Course - Separate Registration Required

  • Instructor:

    

    Tony A. Perry
    Regional Director of Quality, SCHOTT Pharma

  This training course will provide manufacturers and users of glass containers with valuable knowledge related to the quality of glass containers including the types of defects associated with glass manufacture, the development of standardized quality criteria, and sampling plans for use in the quality decision-making process.

  The development of PDA Technical Report No. 43 (Revised 2013): Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing and associated lexicons of glass nonconformities will be described to provide participants with a solid understanding of what is and isn’t in the report and why. Through a series of presentations accompanied by visual depictions of glass nonconformities, participants will be provided with a review of current best practices for identification and classification of visual nonconformities in glass containers. The training course will also present criteria such as the development and use of appropriate sampling plans for incoming inspection of glass containers and the appropriate application of acceptable quality limits for accept/reject decisions. The importance of the partnership between glass manufacturers and the pharmaceutical company using the glass containers in establishing glass container quality specifications will be emphasized.

  Training Course Information and Registration

• 13:00 – 18:00

  Registration Open

• 16:30 – 18:30

  PDA Southeast Chapter Welcome Reception

  Kick off the PDA Visual Inspection Forum 2025 by attending our Welcome Reception at the host hotel. Enjoy a beverage or two and some snacks at this curated networking event with peers and industry leaders, setting the tone for groundbreaking sessions that lie ahead at the forum. Members of the PDA SE Chapter Board will be present and eager to talk with you about local events and ways to get involved with our vibrant PDA community

  Secure Your Spot!

EDT Daylight Time (UTC -4:00)

• 07:30 – 08:30

  Continental Breakfast

• 07:30 – 17:30

  Registration Open

• 08:30 – 10:15

  P1: Regulatory Perspectives and Trends: Foundations and Future Directions in Visual Inspection (Crabtree Ballroom)

  Crabtree Ballroom

  • Moderator:

    

    Rick J. Watson
    Director, Merck & Co., Inc.

  This opening plenary will explore the compendial and regulatory frameworks that shape visual inspection (VI) process design and control, highlighting recent updates and emerging trends. The session will begin with an overview of current regulatory and compendial requirements, emphasizing their implications for inspection practices, and will be followed by a discussion on regulatory expectations for assessing visible particulates in injectable pharmaceuticals, offering insights into compliance and quality standards. These expert presentations will provide valuable insight into navigating the evolving regulatory landscape for VI in pharmaceutical manufacturing.

  • 08:30 – 08:45

    Welcome and Opening Remarks from Co-Chairs

    • Co-Chair:

      

      Romain Veillon, PharmD
      Director Platform Lead Visual Inspection, GSK

    • Co-Chair:

      

      Rick J. Watson
      Director, Merck & Co., Inc.

  • 08:45 – 09:15

    Update on Recent Visual Inspection Compendial Activity

    • Presenter:

      

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

  • 09:15 – 09:45

    Update on Drug Recall Trends and Recent FDA Activity

    • Presenter:

      

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

  • 09:45 – 10:15

    Q&A
• 10:15 – 11:00

  Networking Break in the Exhibit Hall (Sponsored by Brevetti C.E.A. SPA)

• 10:15 – 11:00

  Poster Presentations in the Exhibit Hall

  • 10:15 – 11:00

    (#01) Leveraging Deep Learning and AI-Driven Facial Tracking Systems to Enhance Manual Visual Inspection in Pharmaceutical Manufacturing

    • Poster Presenter:

      

      Ali Yuksel
      Managing Partner | Principal Engineer, YB

  • 10:15 – 11:00

    (#02) Class-Conditional Vial Image Generation Using Diffusion Models for Enhanced Visual Inspection

    • Poster Presenter:

      

      Zhengqi Gao, PhD
      Phd student, MIT

  • 10:15 – 11:00

    (#03) A Comparison of Barrier Film Non-Stick Coated Stoppers vs. Non-Barrier Film Rubber Stoppers in Pharmaceutical Packaging: A Case Study from Historical Data

    • Poster Presenter:

      

      Heather Marzolo, MS
      Laboratory Technician, Sartorius

  • 10:15 – 11:00

    (#04) Manual Visual Inspection Threshold Studies of Container Closure System and Particle Defects

    • Poster Presenter:

      

      Lucas Ramos
      Process Development Engineer, Drug Product, Replimune

  • 10:15 – 11:00

    (#05) Redefining Visual Inspection Particle Detectability Limits for Standardized Operator Qualification

    • Poster Presenter:

      

      Filip M. Fedorowicz, MSc
      Associate Principal Scientist, Clear Solutions Laboratories AG

  • 10:15 – 11:00

    (#07) Visible Particles within Cell Therapies: A Holistic and Strategic Approach to Characterize, Identify, and De-Risk the Presence of Visible Particulates in ATMP Drug Product Formulations

    • Poster Presenter:

      

      Randall Thompson
      Director, MSAT Aseptic Controls, Vertex

  • 10:15 – 11:00

    (#09) Linear Inspection of DIPs – A Valid Alternative to Conventional Inspection Methods for the Inspection of Lyophilized Products in Vials

    • Poster Presenter:

      

      Sebastian Mayer
      Product Manager, HEUFT SYSTEMTECHNIK GMBH

  • 10:15 – 11:00

    (#10) Relationships Between Visual Inspection Detectability and Liquid Extraction Measurement of Particulate Matter in Bioprocess Containers

    • Poster Presenter:

      

      Klaus R. Wormuth, PhD
      Principal Scientist, Sartorius

  • 10:15 – 11:00

    (#11) Different Types of Test Sets Throughout a Visual Inspection Project Lifecycle: From Vendor Selection to Visual Inspection in Production

    • Poster Presenter:

      

      Menno Sels, MA
      Senior Process & Project Engineer, eyetec

  • 10:15 – 11:00

    (#12) Test Kit Fabrication Lab

    • Poster Presenter:

      

      Christopher L. Barnes
      Advisor -Global Visual Inspection Steward, Eli Lilly

• 11:00 – 12:45

  P2: Advancing Process Development: Enhancing Manual Visual Inspection for Emerging Challenges (Crabtree Ballroom)

  Crabtree Ballroom

  • Moderator:

    

    Romain Veillon, PharmD
    Director Platform Lead Visual Inspection, GSK

  Manual visual inspection (MVI) remains the gold standard for establishing baseline performance, yet evolving product modalities present new challenges. This session will explore strategies to enhance MVI processes and address the unique hurdles posed by gene and cell therapy production. After an examination of the complexities of inspecting products ranging from clear glass containers to opaque plastics in gene and cell therapy a case study showcasing practical methods to boost MVI efficiency and effectiveness will be presented. Attendees will leave with actionable insights into optimizing MVI processes to meet the demands of modern biopharmaceutical manufacturing.

  • 11:00 – 11:15

    Interactive Polling
  • 11:15 – 11:45

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

    • Presenter:

      

      Ines Bauer, MSc
      Expert Science & Technology, Novartis

  • 11:45 – 12:15

    How to Boost Your MVI: A Case Study to Improve Efficiency

    • Presenter:

      

      Antonio Burazer
      Global Head Visual Inspection & Particle LCM, Takeda

  • 12:15 – 12:45

    Q&A
• 12:45 – 13:45

  Networking Lunch with Exhibitors

  Glenwood Ballroom

• 13:15 – 13:30

  Guided Poster Walk

• 13:45 – 15:15

  A1: New Challenges in Visual Inspection Qualification: Navigating Innovation and Global Complexity (Crabtree Ballroom)

  Crabtree Ballroom

  • Moderator:

    

    Andrea Sardella, PhD
    Customer Success Manager, Brevetti CEA

  Advancements in visual inspection (VI) technologies, the rise of difficult-to-inspect parenteral (DIP) products, and the global reach of pharmaceutical organizations present fresh challenges to the qualification process. This session will examine key aspects of adopting and validating modern technologies, including AI-driven inspection models and automated recirculation functions. Case studies from industry leaders will highlight practical solutions, technical details, and innovative validation strategies. The final presentation will showcase the development of a global standard operating procedure, emphasizing adaptability and continuous training to meet evolving global demands. These insights will encourage critical thinking about the future of VI qualification.

  • 13:45 – 14:05

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

    • Presenter:

      

      Christy Eatmon
      Global SME Sterile Drug Products, Thermo Fisher Scientific

    • Co-Presenter:

      

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

  • 14:05 – 14:25

    Qualifying an Automated VI Using Recirculation Function

    • Presenter:

      

      Jun L. Ordonez, MS Quality Systems
      Senior Manager, Pfizer

  • 14:25 – 14:45

    Development of a Global Standard Operating Procedure Development Case Study for Both Liquid and DIP

    • Presenter:

      

      Pere Joaquin, MSc, PG, PharmB
      Site Quality Unit Director and QP, Reig Jofre

  • 14:45 – 15:15

    Q&A
• 13:45 – 15:15

  B1: Advances in Particle Control and Monitoring: Building a Compliant and Effective Framework

  City of Oaks Ballroom

  • Moderator:

    

    Robert J. Miller, MS
    Independent Consultant, R. J. Miller and Associates

  Particle control and monitoring are critical to ensuring compliance and efficiency in parenteral manufacturing. This session will explore the interconnected components of a robust program, including supplier relationships, upstream process monitoring, and visual inspection. The presenters will delve into practical strategies such as solving trace foreign matter investigations, reducing particles through supplier-driven contamination control strategies (CCS), and pinpointing cellulose sources. These advanced concepts will illustrate how a mature particle control program can drive continuous improvement and enhance manufacturing capabilities, setting new standards for process excellence.

  • 13:45 – 14:05

    Problem Solving During Trace Foreign Matter Investigations: Points to Consider

    • Presenter:

      

      Mary Lee Ciolkowski, PhD
      Senior Principal Scientist, Bausch + Lomb

  • 14:05 – 14:25

    Achieving Particle Reduction via Supplier Contamination Control Strategies and Innovation in Ready-toT-Fill Packaging

    • Presenter:

      

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

  • 14:25 – 14:45

    Cellulose – Understanding and Narrowing Down Its Sources

    • Presenter:

      

      Casey M. Jarvis
      Research Scientist, MVA Scientific Consultants

  • 14:45 – 15:15

    Q&A
• 15:15 – 16:00

  Networking Break in the Exhibit Hall

  Glenwood Ballroom

• 15:15 – 16:00

  Poster Presentations in the Exhibit Hall

  Glenwood Ballroom

  • 15:15 – 16:00

    (#01) Leveraging Deep Learning and AI-Driven Facial Tracking Systems to Enhance Manual Visual Inspection in Pharmaceutical Manufacturing

    • Poster Presenter:

      

      Ali Yuksel
      Managing Partner | Principal Engineer, YB

  • 15:15 – 16:00

    (#02) Class-Conditional Vial Image Generation Using Diffusion Models for Enhanced Visual Inspection

    • Poster Presenter:

      

      Zhengqi Gao, PhD
      Phd student, MIT

  • 15:15 – 16:00

    (#03) A Comparison of Barrier Film Non-Stick Coated Stoppers vs. Non-Barrier Film Rubber Stoppers in Pharmaceutical Packaging: A Case Study from Historical Data

    • Poster Presenter:

      

      Heather Marzolo, MS
      Laboratory Technician, Sartorius

  • 15:15 – 16:00

    (#04) Manual Visual Inspection Threshold Studies of Container Closure System and Particle Defects

    • Poster Presenter:

      

      Lucas Ramos
      Process Development Engineer, Drug Product, Replimune

  • 15:15 – 16:00

    (#05) Redefining Visual Inspection Particle Detectability Limits for Standardized Operator Qualification

    • Poster Presenter:

      

      Filip M. Fedorowicz, MSc
      Associate Principal Scientist, Clear Solutions Laboratories AG

  • 15:15 – 16:00

    (#07) Visible Particles within Cell Therapies: A Holistic and Strategic Approach to Characterize, Identify, and De-Risk the Presence of Visible Particulates in ATMP Drug Product Formulations

    • Poster Presenter:

      

      Randall Thompson
      Director, MSAT Aseptic Controls, Vertex

  • 15:15 – 16:00

    (#09) Linear Inspection of DIPs – A Valid Alternative to Conventional Inspection Methods for the Inspection of Lyophilized Products in Vials

    • Poster Presenter:

      

      Sebastian Mayer
      Product Manager, HEUFT SYSTEMTECHNIK GMBH

  • 15:15 – 16:00

    (#10) Relationships Between Visual Inspection Detectability and Liquid Extraction Measurement of Particulate Matter in Bioprocess Containers

    • Poster Presenter:

      

      Klaus R. Wormuth, PhD
      Principal Scientist, Sartorius

  • 15:15 – 16:00

    (#11) Different Types of Test Sets Throughout a Visual Inspection Project Lifecycle: From Vendor Selection to Visual Inspection in Production

    • Poster Presenter:

      

      Menno Sels, MA
      Senior Process & Project Engineer, eyetec

  • 15:15 – 16:00

    (#12) Test Kit Fabrication Lab

    • Poster Presenter:

      

      Christopher L. Barnes
      Advisor -Global Visual Inspection Steward, Eli Lilly

• 16:00 – 17:30

  A2: Innovative AI and Machine Learning Solutions for Visual Inspection for Difficult-to-Inspect Parenterals (Crabtree Ballroom)

  Crabtree Ballroom

  • Moderator:

    

    Antonio Burazer
    Global Head Visual Inspection & Particle LCM, Takeda

  This session will explore cutting-edge AI and machine learning (ML) techniques that improve quality control for challenging pharmaceutical products. The presentations will cover processes designed to streamline automated visual inspection (AVI), including advanced image classification, deep learning for defect identification, and unsupervised learning methods. These innovations enable precise detection of defects, reduce false rejections, and enhance inspection accuracy across a range of difficult-to-inspect parenteral (DIP) products, underscoring AI’s growing impact on quality assurance in the industry.

  • 16:00 – 16:20

    Rule-Based vs. AI Algorithms in DIP Quality Control

    • Presenter:

      

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

  • 16:20 – 16:40

    AI-Powered AVI: Image Classification Enhancement and False Rejection Rate Reduction in Blow-Fill-Seal DIPs

    • Presenter:

      

      Gianmarco Pincelli
      Technical Sales Manager, Bonfiglioli Engineering

  • 16:40 – 17:00

    Unsupervised ML Applied to DIPs

    • Presenter:

      

      Brian Turnquist, PhD
      Chief Technical Officer, BoonLogic

  • 17:00 – 17:30

    Q&A
• 16:00 – 17:30

  B2: Particle Detection Capability: Identifying and Controlling Contaminants (City of Oaks Ballroom)

  City of Oaks Ballroom

  • Moderator:

    

    Romain Veillon, PharmD
    Director Platform Lead Visual Inspection, GSK

  Understanding the source and composition of particles is a crucial part of the visible particle control strategy. This session will discuss issues related to particle detectability under standard inspection conditions. A comprehensive overview of the particle detection capabilities will highlight the complexity of particle sources and approaches for the reduction of the particle contamination in the manufacturing environment. Additionally, the session will feature a manual visual inspection (MVI) case study and introduce an innovative approach to identifying particles in parenteral products.

  • 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

  • 16:20 – 16:40

    3D Printed Protein-Like Model Particles: Standards for Performance Evaluation of Novel Human-Inspired Automated Visual Inspection Instruments

    • Presenter:

      

      Oliver Germershaus, PhD
      Professor for Pharmaceutical Technology of Macromolecular Drugs, University of Applied Sciences and Arts Northwestern Switzerland

  • 16:40 – 17:00

    Case Studies: Increasing MVI Detection Probability in Difficult-to-Inspect Products

    • Presenter:

      

      Bram Keymolen, MS
      Co-Founder, eyetec

  • 17:00 – 17:30

    Q&A
• 17:30 – 18:30

  Networking Reception in the Exhibit Hall

EDT Daylight Time (UTC -4:00)

• 07:30 – 08:30

  Continental Breakfast

• 07:30 – 17:00

  Registration Open

• 08:30 – 10:00

  P3: Visual Inspection Acceptance Sampling and Performance Metrics: Enhancing Quality and Inspection Validation

  Crabtree Ballroom

  • Moderator:

    

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

  This session will address critical aspects of acceptance sampling and performance measurement in visual inspection (VI), offering insights into practical considerations and common misconceptions. Subject matter experts will examine the role of acceptance quality limit (AQL) sampling in evaluating batch quality and trending defects following 100% VI as well as introduce mathematical models used to compare the detection performance of manual visual inspection (MVI) versus automated visual inspection (AVI), essential for qualifying and validating alternative inspection methods. Participants will gain a deeper understanding of how sampling and performance metrics enhance inspection reliability and ensure product quality.

  • 08:30 – 09:00

    Sampling in the VI Process: AQL and Defect Trending

    • Presenter:

      

      Robert J. Miller, MS
      Independent Consultant, R. J. Miller and Associates

  • 09:00 – 09:30

    Mathematical Modeling to Compare Detection Performance: MVI vs. AVI

    • Presenter:

      

      Mark Arsenault
      Senior Process Engineer, Genentech

  • 09:30 – 10:00

    Q&A
• 10:00 – 10:45

  Networking Break in the Exhibit Hall

• 10:00 – 10:45

  Poster Presentations in the Exhibit Hall

  Glenwood Ballroom

  • 10:00 – 10:45

    (#01) Leveraging Deep Learning and AI-Driven Facial Tracking Systems to Enhance Manual Visual Inspection in Pharmaceutical Manufacturing

    • Poster Presenter:

      

      Ali Yuksel
      Managing Partner | Principal Engineer, YB

  • 10:00 – 10:45

    (#02) Class-Conditional Vial Image Generation Using Diffusion Models for Enhanced Visual Inspection

    • Poster Presenter:

      

      Zhengqi Gao, PhD
      Phd student, MIT

  • 10:00 – 10:45

    (#03) A Comparison of Barrier Film Non-Stick Coated Stoppers vs. Non-Barrier Film Rubber Stoppers in Pharmaceutical Packaging: A Case Study from Historical Data

    • Poster Presenter:

      

      Heather Marzolo, MS
      Laboratory Technician, Sartorius

  • 10:00 – 10:45

    (#04) Manual Visual Inspection Threshold Studies of Container Closure System and Particle Defects

    • Poster Presenter:

      

      Lucas Ramos
      Process Development Engineer, Drug Product, Replimune

  • 10:00 – 10:45

    (#05) Redefining Visual Inspection Particle Detectability Limits for Standardized Operator Qualification

    • Poster Presenter:

      

      Filip M. Fedorowicz, MSc
      Associate Principal Scientist, Clear Solutions Laboratories AG

  • 10:00 – 10:45

    (#07) Visible Particles within Cell Therapies: A Holistic and Strategic Approach to Characterize, Identify, and De-Risk the Presence of Visible Particulates in ATMP Drug Product Formulations

    • Poster Presenter:

      

      Randall Thompson
      Director, MSAT Aseptic Controls, Vertex

  • 10:00 – 10:45

    (#09) Linear Inspection of DIPs – A Valid Alternative to Conventional Inspection Methods for the Inspection of Lyophilized Products in Vials

    • Poster Presenter:

      

      Sebastian Mayer
      Product Manager, HEUFT SYSTEMTECHNIK GMBH

  • 10:00 – 10:45

    (#10) Relationships Between Visual Inspection Detectability and Liquid Extraction Measurement of Particulate Matter in Bioprocess Containers

    • Poster Presenter:

      

      Klaus R. Wormuth, PhD
      Principal Scientist, Sartorius

  • 10:00 – 10:45

    (#11) Different Types of Test Sets Throughout a Visual Inspection Project Lifecycle: From Vendor Selection to Visual Inspection in Production

    • Poster Presenter:

      

      Menno Sels, MA
      Senior Process & Project Engineer, eyetec

  • 10:00 – 10:45

    (#12) Test Kit Fabrication Lab

    • Poster Presenter:

      

      Christopher L. Barnes
      Advisor -Global Visual Inspection Steward, Eli Lilly

• 10:45 – 12:15

  A3: Transforming Visual Inspection: Strategies for Modernization and Training (Crabtree Ballroom)

  Crabtree Ballroom

  • Moderator:

    

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

  This session will explore how modernizing visual inspection (VI) processes can improve defect detection. Topics will include the revision of manual inspection programs, the transition to automated systems, and the importance of inspector training for ensuring accuracy and compliance. Participants will be provided with practical strategies to improve inspection workflows, implement automated visual inspection (AVI) systems, and foster robust training practices to boost product quality.

  • 10:45 – 11:05

    Challenges and Considerations in Transitioning from Manual to AVI

    • Presenter:

      

      Andrea Sardella, PhD
      Customer Success Manager, Brevetti CEA

  • 11:05 – 11:25

    Revolutionizing Pharmaceutical Inspection: Upgrading to AVI Systems

    • Presenter:

      

      Bill Waterstreet
      Principal Validation Engineer, Performance Validation

  • 11:25 – 11:45

    Manual VI Inspector Training and Qualification

    • Presenter:

      

      Tracey Sinjen
      Principal Consultant, Lachman Consultants

  • 11:45 – 12:15

    Q&A
• 10:45 – 12:15

  B3: Novel Inspection Equipment Design and Application: Enhancing Detection and Efficiency

  City of Oaks Ballroom

  • Moderator:

    

    Rick J. Watson
    Director, Merck & Co., Inc.

  This session will delve into the latest advancements in inspection equipment technology, showcasing innovations that enhance defect detection, streamline processes, and improve data collection. Presentations will include AI-driven visual inspection (VI) systems that leverage data for smarter production, a semi-automated IV bag inspection system (IVBIS), and the integration of complete electronic records in VI processes. These cutting-edge solutions will demonstrate how modern equipment design is driving efficiency and quality in pharmaceutical manufacturing.

  • 10:45 – 11:05

    AI-Driven VI: Unlocking Data for Smarter Production

    • Presenter:

      

      Massimo Frasson
      CEO & General Manager, Brevetti CEA

  • 11:05 – 11:25

    A Semi-Automated IVBIS

    • Presenter:

      

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

  • 11:25 – 11:45

    The Next Phase in VI – Complete Electronic Records

    • Presenter:

      

      Gerald Budd
      President, Phoenix Imaging Ltd.

  • 11:45 – 12:15

    Q&A
• 12:15 – 13:15

  Networking Lunch with Exhibitors

  Glenwood Ballroom

• 12:45 – 13:00

  Guided Poster Walk

• 13:15 – 14:45

  P4: Modernizing Visual Inspection: Validation and Digital Transformation in Pharmaceutical Quality Control (Crabtree Ballroom)

  Crabtree Ballroom

  • Moderator:

    

    Antonio Burazer
    Global Head Visual Inspection & Particle LCM, Takeda

  This session will examine the critical aspects of validating both traditional and advanced visual inspection (VI) technologies while exploring the transformative impact of digital VI platforms. The first presentations will discuss defect set design and validation, addressing the advantages of manufactured versus naturally occurring defects in manual and automated inspections. Following this, a holistic, digitally integrated VI platform that standardizes inspection practices, incorporates human oversight, and enables continuous improvement through advanced defect tracking, digital image libraries, and deep learning infrastructure will be introduced. Together, these subject matter experts will illustrate how both validation and digital innovation are reshaping VI for parenterals.

  • 13:15 – 13:45

    VI Validation Considerations for Traditional and New Technology

    • Presenter:

      

      Rick J. Watson
      Director, Merck & Co., Inc.

  • 13:45 – 14:15

    Benefits of a Digital VI Platform

    • Presenter:

      

      Romain Veillon, PharmD
      Director Platform Lead Visual Inspection, GSK

  • 14:15 – 14:45

    Q&A
• 14:45 – 15:30

  Networking Break in the Exhibit Hall

  Glenwood Ballroom

• 15:00 – 15:45

  Poster Presentations in the Exhibit Hall

  Glenwood Ballroom

  • 15:00 – 15:45

    (#01) Leveraging Deep Learning and AI-Driven Facial Tracking Systems to Enhance Manual Visual Inspection in Pharmaceutical Manufacturing

    • Poster Presenter:

      

      Ali Yuksel
      Managing Partner | Principal Engineer, YB

  • 15:00 – 15:45

    (#02) Class-Conditional Vial Image Generation Using Diffusion Models for Enhanced Visual Inspection

    • Poster Presenter:

      

      Zhengqi Gao, PhD
      Phd student, MIT

  • 15:00 – 15:45

    (#03) A Comparison of Barrier Film Non-Stick Coated Stoppers vs. Non-Barrier Film Rubber Stoppers in Pharmaceutical Packaging: A Case Study from Historical Data

    • Poster Presenter:

      

      Heather Marzolo, MS
      Laboratory Technician, Sartorius

  • 15:00 – 15:45

    (#04) Manual Visual Inspection Threshold Studies of Container Closure System and Particle Defects

    • Poster Presenter:

      

      Lucas Ramos
      Process Development Engineer, Drug Product, Replimune

  • 15:00 – 15:45

    (#05) Redefining Visual Inspection Particle Detectability Limits for Standardized Operator Qualification

    • Poster Presenter:

      

      Filip M. Fedorowicz, MSc
      Associate Principal Scientist, Clear Solutions Laboratories AG

  • 15:00 – 15:45

    (#07) Visible Particles within Cell Therapies: A Holistic and Strategic Approach to Characterize, Identify, and De-Risk the Presence of Visible Particulates in ATMP Drug Product Formulations

    • Poster Presenter:

      

      Randall Thompson
      Director, MSAT Aseptic Controls, Vertex

  • 15:00 – 15:45

    (#09) Linear Inspection of DIPs – A Valid Alternative to Conventional Inspection Methods for the Inspection of Lyophilized Products in Vials

    • Poster Presenter:

      

      Sebastian Mayer
      Product Manager, HEUFT SYSTEMTECHNIK GMBH

  • 15:00 – 15:45

    (#10) Relationships Between Visual Inspection Detectability and Liquid Extraction Measurement of Particulate Matter in Bioprocess Containers

    • Poster Presenter:

      

      Klaus R. Wormuth, PhD
      Principal Scientist, Sartorius

  • 15:00 – 15:45

    (#11) Different Types of Test Sets Throughout a Visual Inspection Project Lifecycle: From Vendor Selection to Visual Inspection in Production

    • Poster Presenter:

      

      Menno Sels, MA
      Senior Process & Project Engineer, eyetec

  • 15:00 – 15:45

    (#12) Test Kit Fabrication Lab

    • Poster Presenter:

      

      Christopher L. Barnes
      Advisor -Global Visual Inspection Steward, Eli Lilly

• 15:30 – 17:00

  P5: Panel Discussion: Interactive Insights from Industry Experts

  Crabtree Ballroom

  • Moderator:

    

    Romain Veillon, PharmD
    Director Platform Lead Visual Inspection, GSK

  • Moderator:

    

    Rick J. Watson
    Director, Merck & Co., Inc.

  This final panel discussion will offer conference attendees a unique opportunity to engage directly with the organizing committee of subject matter experts. Participants will be able to ask questions and discuss various topics, fostering an open dialogue that enhances understanding and collaboration within the field. This interactive session aims to address attendee inquiries and provide valuable insights from experienced professionals.

  • 15:30 – 15:45

    Interactive Polling
  • 15:45 – 16:55

    Panel Discussion

    • Panelist:

      

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

    • Panelist:

      

      Antonio Burazer
      Global Head Visual Inspection & Particle LCM, Takeda

    • Panelist:

      

      Robert J. Miller, MS
      Independent Consultant, R. J. Miller and Associates

    • Panelist:

      

      Andrea Sardella, PhD
      Customer Success Manager, Brevetti CEA

    • Panelist:

      

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

    • 

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

  • 16:55 – 17:00

    Closing Remarks from Co-Chairs

EDT Daylight Time (UTC -4:00)

• 08:30 – 17:00

  Fundamentals of Visual Inspection Training Course (Day 1) - Separate Registration Required

  Apella (12 Davis Drive, Durham, NC 27709)

  • Instructor:

    

    Ronald Leversee
    QA External Operations Manager, Padagis US LLC

  • Instructor:

    

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

  Please note that this training course takes place at Apella in Durham, NC.

  This training course covers the fundamentals of visual inspection and their application to injectable products. It will be a combination of lecture/discussion and hands-on exercises used to develop and practice practical inspection skills. The skills developed through this training course may be applied to both manual human inspection and automated machine inspection.

  During this training course, you will learn about patient risks associated with particles in injections; global compendial and regulatory requirements and expectations; inspection techniques for visible particles and container closure defects; critical quality parameters for manual, semi-automated and automated inspection methods; light measurement and control; key elements of a visual inspection program; and inspection lifecycle development.

  Training Course Information and Registration

EDT Daylight Time (UTC -4:00)

• 08:00 – 16:00

  Fundamentals of Visual Inspection Training Course (Day 2) - Separate Registration Required

  Apella (12 Davis Drive, Durham, NC 27709)

  • Instructor:

    

    Ronald Leversee
    QA External Operations Manager, Padagis US LLC

  • Instructor:

    

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

  Please note that this training course takes place at Apella in Durham, NC.

  This training course covers the fundamentals of visual inspection and their application to injectable products. It will be a combination of lecture/discussion and hands-on exercises used to develop and practice practical inspection skills. The skills developed through this training course may be applied to both manual human inspection and automated machine inspection.

  During this training course, you will learn about patient risks associated with particles in injections; global compendial and regulatory requirements and expectations; inspection techniques for visible particles and container closure defects; critical quality parameters for manual, semi-automated and automated inspection methods; light measurement and control; key elements of a visual inspection program; and inspection lifecycle development.

  Training Course Information and Registration

Posters

• Ali Yuksel, Managing Partner | Principal Engineer, YB

• Zhengqi Gao, PhD, Phd student, MIT

• Heather Marzolo, MS, Laboratory Technician, Sartorius

• Lucas Ramos, Process Development Engineer, Drug Product, Replimune

• Filip M. Fedorowicz, MSc, Associate Principal Scientist, Clear Solutions Laboratories AG

• Randall Thompson, Director, MSAT Aseptic Controls, Vertex

• Sebastian Mayer, Product Manager, HEUFT SYSTEMTECHNIK GMBH

• Klaus R. Wormuth, PhD, Principal Scientist, Sartorius

• Menno Sels, MA, Senior Process & Project Engineer, eyetec

• Christopher L. Barnes, Advisor -Global Visual Inspection Steward, Eli Lilly