PDA Visual Inspection Forum 2025

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

  • Moderator:

    

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

  • 08:30 – 08:45

    Welcome and Opening Remarks from Forum Co-Chairs

    • Co-Chair:

      

      Romain Veillon
      Director Vision Technology, GSK

    • Co-Chair:

      

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

  • 08:45 – 09:15

    Visual Inspection Regulatory and Compendial Update

    • Presenter:

      

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

  • 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

  • 09:45 – 10:15

    Q&A
• 10:15 – 11:00

  Networking Break in the Exhibit Hall

• 10:15 – 11:00

  Poster Presentations in the Exhibit Hall

  • 10:15 – 11:00

    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
      Laboratory Technician, Sartorius

  • 10:15 – 11:00

    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

• 11:00 – 12:45

  P2: Process Development

  • Moderator:

    

    Romain Veillon
    Director Vision Technology, GSK

  • 11:00 – 11:15

    Interactive Polling Questionnaire
  • 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
      Expert Science & Technology, Novartis

  • 11:45 – 12:15

    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

  • 12:15 – 12:45

    Q&A
• 12:45 – 13:45

  Networking Lunch with Exhibitors

• 13:45 – 15:15

  A1: New Challenges in Visual Inspection Qualification

  • Moderator:

    

    Andrea Sardella, PhD
    

  • 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
      Head of Data Science, InspectifAI

  • 14:05 – 14:25

    Qualifying an Automated Visual Inspection Using Recirculation Function

    • Presenter:

      

      Jun L. Ordonez
      Senior Manager, Pfizer

  • 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

  • 14:45 – 15:15

    Q&A
• 13:45 – 15:15

  B1: Advances in Particle Investigations

  • Moderator:

    

    Robert J. Miller
    Director, Technical Services, Pfizer

  • 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 RTF 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

• 15:15 – 16:00

  Poster Presentations in the Exhibit Hall

  • 15:15 – 16:00

    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
      Laboratory Technician, Sartorius

  • 15:15 – 16:00

    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

• 16:00 – 17:30

  A2: Particle Detection Capability

  • Moderator:

    

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

  • 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 as Particle Standards for Performance Evaluation of Novel Human-Inspired Automated Visual Inspection Instrument

    • 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 PoD in Manual Visual Inspection for DIP

    • Presenter:

      

      Bram J.J. Keymolen
      Co-Founder, eyetec

  • 17:00 – 17:30

    Q&A
• 16:00 – 17:30

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

  • Moderator:

    

    Antonio Burazer
    Global Head Visual Inspection & Particle LCM, Takeda

  • 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

  • 16:20 – 16:40

    Enhancing Image Classification and Reducing False Rejection Rates in BFS DIP Products Using AI on Automated Visual Inspection Systems

    • Presenter:

      

      Gianmarco Pincelli
      Technical Sales Manager, Bonfiglioli Engineering

  • 16:40 – 17:00

    Unsupervised Machine Learning Applied to Difficult-to-Inspect Products

    • Presenter:

      

      Brian Turnquist, PhD
      Chief Technical Officer, BoonLogic

  • 17:00 – 17:30

    Q&A
• 17:30 – 18:30

  Networking Reception in 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 Measurement

  • Moderator:

    

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

  • 08:30 – 09:00

    Sampling in the Visual Inspection Process: AQL and Defect Trending

    • Presenter:

      

      Robert J. Miller
      Director, Technical Services, Pfizer

  • 09:00 – 09:30

    Use of Mathematical Model for Detection Performances Comparison of Manual Visual Inspection vs. Automated Visual Inspection

    • Presenter:

      

      Mark Arsenault
      

  • 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

  • 10:00 – 10:45

    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
      Laboratory Technician, Sartorius

  • 10:00 – 10:45

    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

• 10:45 – 12:15

  A3: Inspection Optimization

  • Moderator:

    

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

  • 10:45 – 11:05

    Transitioning from Manual to Automated Visual Inspection

    • Presenter:

      

      Andrea Sardella, PhD
      

  • 11:05 – 11:25

    Revolutionizing Pharmaceutical Inspection: Upgrading to Automated Visual Inspection Systems

    • Presenter:

      

      Bill Waterstreet
      Principal Validation Engineer, Performance Validation

  • 11:25 – 11:45

    Manual Visual Inspection and 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

  • Moderator:

    

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

  • 10:45 – 11:05

    AI-Driven Visual Inspection: Unlocking Data for Smarter Production

    • Presenter:

      

      Massimo Frasson
      CEO & General Manager, Brevetti CEA

  • 11:05 – 11:25

    A Semi-Automated IV Bag Inspection System

    • Presenter:

      

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

  • 11:25 – 11:45

    The Next Phase in Visual Inspection – Complete Electronic Records

    • Presenter:

      

      Gerlad Budd
      President, Phoenix Imaging Ltd.

  • 11:45 – 12:15

    Q&A
• 12:15 – 13:15

  Networking Lunch with Exhibitors

• 13:15 – 14:45

  P4: Visual Inspection Process Development and Qualification

  • Moderator:

    

    Antonio Burazer
    Global Head Visual Inspection & Particle LCM, Takeda

  • 13:15 – 13:45

    Visual Inspection Validation Considerations for Traditional and New Technology

    • Presenter:

      

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

  • 13:45 – 14:15

    Benefit of Digital Visual Inspection Platform

    • Presenter:

      

      Romain Veillon
      Director Vision Technology, GSK

  • 14:15 – 14:45

    Q&A
• 14:45 – 15:30

  Networking Break in the Exhibit Hall

• 15:00 – 15:45

  Poster Presentations in the Exhibit Hall

  • 15:00 – 15:45

    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
      Laboratory Technician, Sartorius

  • 15:00 – 15:45

    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

• 15:30 – 17:00

  P5: Panel Discussion

  • Moderator:

    

    Romain Veillon
    Director Vision Technology, GSK

  • Moderator:

    

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

  • 15:30 – 15:45

    Interactive Polling Questionnaire
  • 15:45 – 16:55

    Panel Discussion

    • Panelist:

      

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

    • Panelist:

      

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

    • Panelist:

      

      Robert J. Miller
      Director, Technical Services, Pfizer

    • Panelist:

      

      Andrea Sardella, PhD
      

    • Panelist:

      

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

    • Panelist:

      

      Romain Veillon
      Director Vision Technology, GSK

    • Panelist:

      

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

    • Panelist:

      

      Linda Wildling, PhD
      Head of Digital Innovation Success Management, Takeda

  • 16:55 – 17:00

    Closing Remarks from Forum Co-Chairs

    • Co-Chair:

      

      Romain Veillon
      Director Vision Technology, GSK

    • Co-Chair:

      

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

Posters

• Heather Marzolo, Laboratory Technician, Sartorius

• Ali Yuksel, Managing Partner | Principal Engineer, YB