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2023 Visual

2023 PDA Visual Inspection Forum

Apr 17 - Apr 18, 2023
Baltimore, MD

Innovation and Efficiency

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  • The Americas
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Program Highlights

Get your VI questions answered by the experts! Throughout the conference, there will be plenty of opportunities to talk to the experts, including at the Ask the Experts interactive panel discussion, Q&A discussions following every session, and networking breaks.

Overview

The Program Planning Committee invites you to participate in the 2023 PDA Visual Inspection Forum! Visual inspection (VI) continues to be critical to the manufacture and delivery of high-quality injectable medicines. This forum provides a platform to present and discuss new developments and expectations in the field of VI. This year we have returned to an in-person meeting after the success of the live event in Berlin in 2022.

The regulatory and compendial environment continues to rapidly evolve with new or revised guidance published this year. FDA has published a draft of their Inspection of Injectable Products for Visible Particulates guidance for industry and USP and EMA have finalized updates to USP <1790> and Annex 1, respectively. These new requirements encourage further discussion of the correct understanding and implementation of VI within the pharmaceutical manufacturing supply chain and provide one of this year‘s hot topics.

Automated visual inspection (AVI) provides significant benefits when integrated into the manufacturing process. This is especially true for mass market products such as the recent expansion of COVID vaccine production. Technological advancements, like the use of AI in image analysis and inspection recipe development, can offer significant performance improvements for AVI. Such advancements and other practical case studies on AVI implementation are planned for the agenda in 2023.

As in previous years, manual inspection remains an important means of monitoring and controlling product quality and the most widely used method for visual inspection. It continues to be the pharmacopeial reference method and practical experience with this method will also be addressed. Discussion of the key elements of a basic inspection and sampling process along with special considerations for difficult to inspect parenteral (DIP) products such as lyophilized and biopharmaceutical products, and those in special packing types are planned.
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Agenda

  • Day 1
  • Day 2
  • Posters

  • MONDAY, 17 APRIL

    07:30 – 08:30 | Continental Breakfast

    08:15 – 10:00 | P1: Regulatory Perspectives
    Moderator: Rukman De Silva, PhD, Policy Lead, OPQ, CDER, U.S. FDA

    Visual inspection of parenterals is a critical part of the manufacturing and quality control process, and it’s highly regulated by Health Agencies and Pharmacopeias. This session will cover regulations that govern visual inspection and particle control. Also, the latest regulatory and compendial updates from U.S. FDA, USP and EMA will be presented. 

    08:15 | Welcome and Opening Remarks from Forum Co-Chairs 
    John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
    Romain Veillon, PharmD, Director Vision Technology, GSK Vaccines

    08:30 | Particulate Matter Detection and Identification in Biologic Drug Products
    Ashwinkumar Bhirde, PhD,     Senior Research Scientist, OPQ, CDER, U.S. FDA 

    09:00 | VI Regulatory and Compendial Update: What's New at FDA, USP, and EMA
    John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    9:30 | Q&A

    10:00 – 10:45 | Refreshment Break and Poster Presentations in the Exhibit Hall

    10:45 – 12:15 | P2: Visual Inspection Trends
    Moderator: John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    This session provides the first report of updated industry benchmarking conducted through PDA to provide a look at current industry visual inspection practices and results.  This report is followed by a case study in using inspection results to drive continuous process improvement in routine inspections.  Both talks will provide insight into current good practices in VI programs in use today and which may benefit your clinical and commercial operations. 

    10:45 | Review of the 2023 PDA Visual Inspection Survey Results
    Rick J. Watson,     Director, Sterile and Validation Center of Excellence, Merck & Co., Inc.

    11:15 | How Lifecycle Management Impacts Success of Visual Inspection and Defect Control Implementation
    Mariana Araujo Siqueira,     Manager, Quality Operations & Strategy, Baxter Healthcare

    11:45 | Q&A

    12:15 – 13:30 | Networking Lunch

    13:30 – 15:00 | Concurrent Sessions

    A1: Manual Visual Inspection
    Moderator:     Elizabeth Zybczynski, Director, Production and Process Control, Baxter Healthcare

    This session will touch on the different experiences in the development, execution, and maintenance of human qualification programs.

    13:30 | Manual Visual Inspection (MVI) and Inspector Training and Qualification
     Emily Beattie, Global Quality Operations and Strategy, Baxter Healthcare

    13:50 | Optimized Visual Inspection Training, Qualification, and Challenge Standards Data Management
    Roy T. Cherris, Senior Advisor and CSO, Bridge Associates Int'l Consulting and InQuest Science
    Dan Berdovich, President, Micro Measurement Labs

    14:10 | Assessing Visual Inspection Performance Across a Global Network of Manufacturing Sites: How to Execute a Global Threshold Study
     Antonio Burazer, Global Head Visual Inspection & Particle LCM, Takeda Pharmaceuticals International AG

    14:30 | Q&A

    B1: Advances in Automated Inspection (Session 1 of 3)
    Moderator: Rick J. Watson,     Director, Sterile and Validation Center of Excellence, Merck & Co., Inc.

    Join us for a review of modern techniques that can be used to qualify automated inspection equipment. We will also be looking at novel applications of machine learning as applied to AVI systems.

    13:30 | Demonstrating Equivalent or Better Performance: Defending Qualification of AVI
    Brady Wern, Lead Process Engineer, Catalent

    13:50 | State of the Art Visual Inspection Using Machine Learning
    Eskild Børsting Sørensen, Data Scientist, Novo Nordisk

    14:10 | Strategies for Integrating Deep Learning in Automated Vision Inspection
    Conor Kennedy, Specialist Engineering, Merck & Co., Inc.

    14:30 | Q&A

    15:00 – 15:45 | Refreshment Break and Poster Presentations in the Exhibit Hall

    15:45 – 17:15 | Concurrent Sessions

    A2: Difficult to Inspect Products and Packages
    Moderator:     Rob J. Miller, Director, Sterile Injectables Technology, Pfizer Inc.

    Not all products and presentations are a clear solution in a clear glass vial.  This session will provide options for traditionally difficult-to-inspect presentations and the use of surrogates in process design. 

    15:45 | Visual Inspection Approaches for Ophthalmic Solutions Packaged in Opaque and Semi-Transparent Containers
    Mary Lee Ciolkowski,     Senior Principal Scientist, Bausch + Lomb

    16:05 | Automatic Inspection of Media Fill Test Kit: Feasibility and Advantages
    Massimo Frasson, General Manager, Brevetti C.E.A. S.p.A.

    16:25 | Surrogate Use for Inspection Qualification: Opportunities and Risks
    Sai Teja Neeli, Senior Process Engineer, Catalent Pharma Solutions

    16:45 | Q&A

    B2: Advances in Automated Inspection (Session 2 of 3)
    Moderator: Linda Wildling, PhD,     Head of Digital Innovation Success Management, Takeda Pharmaceuticals International AG

    This session is a deep dive into A.I. use cases, developed to support state-of-the-art AVI systems. We will be discussing how to reduce scrap, improve detection, and what you should take into account in order to be successful. 

    15:45 | Presentation of Use Cases Using Deep Learning Models in AVI
    Tobias Carlos Tvarnø, Data Scientist, Novo Nordisk A/S

    16:05 | Automated Visual Inspection Based on Unsupervised Machine Learning
    Brian Turnquist, Chief Technical Officer, Boon Logic

    16:25 | Lessons Learned: From a Pilot Study to a Validated Deep Learning Algorithm in Production
    Felix Riehn, MSc, Head of Product Management, Körber Pharma Inspection GmbH

    16:45 | Q&A

    17:15 – 18:30 | Networking Reception in Exhibit Hall

  • TUESDAY, 18 APRIL

    07:30 – 08:30 | Continental Breakfast

    08:30 – 10:00 | P3: Particle Identification
    Moderator: Romain Veillon, PharmD, Director Vision Technology, GSK Vaccines

    In this session, we are going to be delving into why particle characterization is key. Once you know about found particles, you can use this information to drive your quality improvement program. Join us to learn how to take this critical first step! 

    08:30 | Innovative Prototype for Visible Particle Detection, Characterization, and Chemical Identification in Closed Container
    Ilias Amara, Dipl Ing, PhD Candidate, F. Hoffmann-La Roche Ltd

    09:00 | How to Lose a Particle in 5 Ways
    Casey M. Jarvis, MPS,     Research Scientist, MVA Scientific Consultants

    09:30 | Q&A

    10:00 – 10:45 | Refreshment Break and Poster Presentations in Exhibit Hall

    10:45 – 12:15 | Concurrent Sessions

    A3: Container Closure Integrity Testing (CCIT)
    Moderator: Jeffrey Williams, Senior Manager, Process Engineering, Catalent

    Leak Detection technologies are often associated with automated visual inspection systems. What are the benefits of such a combination? How can traceability and serialization benefit the patient? How should we respond to annex1 and USP<1207>?

    10:45 | Impact of Primary Container Traceability on Visual Inspection and CCIT
     Herve Soukiassian, Assoc. Director Product Development, BD
    Christian Kolic, Product Manager Inspection Machines, Koerber

    11:05 | Next Level Automatic Visual Inspection with CCIT and Serialization
    Darryl Peterson,     Business Development Manager, Automated Inspection Machines, Antares Vision Group

    11:25 | High Voltage Leak Detection: An Invaluable Lab Tool for Assessing Container Closure System Compliance to Annex I and USP1207
    Andrea Sardella,     Senior Manager, Stevanato Group

    11:45 | Q&A

    B3: Advances in Automated Inspection (Session 3 of 3)
    Moderator: Felix Riehn, MSc, Head of Product Management, Körber

    TMIT and Novo Nordisk will be presenting use cases to show the benefit of AI and its potential to revolutionize visual inspection for the parenteral product. They will also discuss with us the impact of AI on validation kits will be investigated and how qualification routines may change.  

    10:45 | Achieving Small False Positive Rate for Automated Visual Inspection via a Dual-Threshold Convolutional Neural Network
    Zhengqi Gao, PhD, Research Assistant, Massachusetts Institute of Technology

    11:05 | Evolution of Particles and Cosmetic Validation Kits: What Would Be Their Future with the Arrival of Neural Networks?
    Massimo Frasson, General Manager, Brevetti C.E.A. S.p.A

    11:25 | Using Deep Learning for Visual Inspection
    Gitte Bjørg Windfeldt, Head of Product Supply Manufacturing Intelligence Data Science, Novo Nordisk

    11:45 | Q&A

    12:15 – 13:30 | Networking Lunch

    13:30 – 15:00 | P4: Designing Your Visual Inspection Program
    Moderator: Rick J. Watson, Director, Sterile and Validation Center of Excellence, Merck & Co., Inc.

    The focus of this session will be on how to design a Visual Inspection Program. Hear our speakers address broad perspectives on how to design and establish the organization and policies that are needed to support visual inspection and particulate control processes.  

    13:30 | Optimizing the Visual Inspection Organization
    Rob J. Miller, MS, Director, Sterile Injectables Technology, Pfizer Inc.

    14:00 | How to Establish a Companywide Effective Visual Inspection Program and Lifecycle Particle Control Strategy
    Linda Wildling, PhD, Digital & Data Science Program & Portfolio Manager, Takeda Pharmaceuticals International AG

    14:30 | Q&A

    15:00 – 15:45 | Refreshment Break and Poster Presentations in the Exhibit Hall

    15:45 – 16:45 | P5: Ask the Experts: An Interactive Panel Discussion
    Moderators: John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC and Romain Veillon, PharmD, Director Vision Technology, GSK Vaccines

    The panel discussion has been designed to bring together industry experts to discuss and address any questions remaining after the full program of the PDA Visual Inspection Forum. This is your opportunity to ask your remaining questions. Make sure to bring your questions about regulations, inspection methods and technology, and expected inspection results, and get the answers you need! 
    16:45 | Closing Remarks from Forum Co-Chairs
    J    ohn G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
    Romain Veillon, PharmD, Director Vision Technology, GSK Vaccines

  • The following posters will be presented during each break in the Exhibit Hall

    A Visual Path to 99.999% Product Quality
    Mark Zimmerman,     MBA, Business Development, Kimball Electronics

    Demonstrating Equivalent or Better Performance: Defending Qualification of AVI
    Brady Wern,     Lead Process Engineer, Catalent

    Design of AVI-Equipment Suitable for Machine Learning
    Zihao Geng,     MA, Data Scientist, Norvo Nordisk

    Explainability of Deep Learning Model Decisions on AVIs
    Eskild Børsting Sørensen,     MS, Data Scientist, Norvo Nordisk

    Generation and Use of Synthetic Data for Training of Deep Learning Models for AVI
    Søren Voss,     MSc, Robotics Engineer, Novo Nordisk

    Surrogate Use for Inspection Qualification: Opportunities and Risks
    Sai Teja Neeli,     PhD, Senior Process Engineer, Catalent

    Towards Sub-wavelength Detection of Visually Obstructed Metal Particles in Lyophilized Parenteral Products with Radio-frequency Signals
    Denise Tellbach,     PhD Candidate, Massachusetts Institute of Technology

Networking Opportunities

MONDAY, 17 APRIL

  • 10:00 – 10:45 | Refreshment Break and Poster Presentations in the Exhibit Hall
  • 12:15 – 13:30 | Networking Lunch
  • 15:00 – 15:45 | Refreshment Break and Poster Presentations in the Exhibit Hall
  • 17:15 – 18:30 | Networking Reception in the Exhibit Hall

TUESDAY, 18 APRIL

  • 10:00 – 10:45 | Refreshment Break and Poster Presentations in the Exhibit Hall
  • 12:15 – 13:30 | Networking Lunch
  • 15:00 – 15:45 | Refreshment Break and Poster Presentations in the Exhibit Hall

Highlighted Speakers

Ilias Amara
Ilias Amara
F. Hoffmann-La Roche Ltd
Ashwinkumar Bhirde
Ashwinkumar Bhirde
U.S. FDA
Roy T. Cherris
Roy T. Cherris
Bridge Associates International & InQuest Science LLC
Rukman S. De Silva
Rukman S. De Silva
U.S. FDA
Casey M. Jarvis
Casey M. Jarvis
MVA Scientific Consultants
Robert J. Miller
Robert J. Miller
Pfizer Inc.
Felix Riehn
Felix Riehn
Körber Pharma Inspection GmbH
John G. Shabushnig
John G. Shabushnig
Insight Pharma Consulting, LLC
Romain Veillon
Romain Veillon
GSK Vaccines
Rick J. Watson
Rick J. Watson
Merck & Co., Inc.
Linda Wildling
Linda Wildling
Takeda Pharmaceuticals International AG
Jeffrey Williams
Jeffrey Williams
Catalent
View All

Additional Information

  • Learning Objectives

    Learning Objectives

    At the completion of this meeting, participants will be able to:

    • Describe compendial requirements and regulatory trends to ensure their companies are meeting current and anticipated regulatory expectations
    • Identify advances in inspection technology and the necessary steps to successful implementation
    • Identify critical parameters that affect the inspection process
    • Implement an effective and practical visual inspection process
    • Implement a visual inspection life-cycle
    • Understand and implement a visual inspection life-cycle
  • Who Should Attend
    Departments
    • Engineering
    • Manufacturing
    • Packaging
    • Process Development
    • Quality
    • Technical Services
    • Validation
    Pharmaceutical/Biopharmaceutical Developers
    • Clinical Supplies
    • Parenteral Development
    • Process Development
    Inspection Equipment Suppliers
    • Applications Development
    • Machine Design
    • Sales

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Hyatt Regency Baltimore Inner Harbor

300 Light Street
Baltimore, MD

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Hyatt Regency Baltimore Inner Harbor
  • Accommodations
    Rate: $229 USD for single/double occupancy, plus state and local taxes
    Cut-Off Date: Monday, 20 March 2023 (after this date the discounted PDA rate is no longer guaranteed)
    Check-In: 16:00
    Check-Out: 11:00

    Reservations
    Online:     Click on the reservation link above
    Phone: +1 (410) 528-1234, make sure to give the PDA Group Code, G-PRDA, to receive the discounted conference rate

    Individual Cancellation
    48 hours prior to 23:59 local time the day of arrival or 1 night fee. Obtaining and canceling hotel reservations is the responsibility of the meeting participant. Individuals will be responsible for payment of their own cancellation fees.
  • Amenities
    Experience an exceptional stay at the Baltimore Inner Harbor hotel designed for business and vacation travelers. Discover a unique blend of urban luxury and local hospitality with stylish rooms and suites that give you a sense of home and tech savvy enhancements that keep you productive. The convenient location makes it easy to walk to area museums, historic landmarks and attractions like the National Aquarium and Camden Yards. Enjoy what happens when convenience meets charm at Hyatt Regency Baltimore Inner Harbor.

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By Air

Baltimore/Washington International Thurgood Marshall Airport (BWI) is approximately 12 miles (20km) from the hotel and all major carriers service this airport. Taxi fares from BWI are approximately $35 one way, not including tip, and will take about 20 minutes.

By Car

Hyatt Regency Baltimore Inner Harbor is located at 300 Light Street, Baltimore, MD 21202. Both valet and self-parking are available.

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Hyatt Regency Baltimore Inner Harbor is conveniently located only four blocks from the Metro subway system and only three blocks from the Lightrail. BUS-MTA picks up right outside the hotel, making it easy to explore the area.

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