2023 PDA Visual Inspection Forum
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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.
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.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
Agenda
Discover What's Happening Each Day
MONDAY, 17 APRIL
07:00 – 17:30 | Registration Open
07:30 – 08:30 | Continental Breakfast
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08:15 – 10:00 | P1: Regulatory Perspectives 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. |
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08:15 | Welcome and Opening Remarks from Forum Co-Chairs 08:30 | Particulate Matter Detection and Identification in Biologic Drug Products 09:00 | VI Regulatory and Compendial Update: What's New at FDA, USP, and EMA |
10:00 – 10:45 | Refreshment Break and Poster Presentations in the Exhibit Hall
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10:45 – 12:15 | P2: Visual Inspection Trends 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. |
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10:45 | Review of the 2023 PDA Visual Inspection Survey Results 11:15 | How Lifecycle Management Impacts Success of Visual Inspection and Defect Control Implementation |
12:15 – 13:30 | Lunch
13:30 – 15:00 | Concurrent Sessions
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A1: Manual Visual Inspection (MVI) This session will touch on the different experiences in the development, execution, and maintenance of human qualification programs. |
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13:30 | Manual Visual Inspection (MVI) and Inspector Training and Qualification 13:50 | Optimized Visual Inspection Training, Qualification and Challenge Standards Data Management 14:10 | Assessing Visual Inspection Performance Across a Global Network of Manufacturing Sites - How to Execute a Global Threshold Study |
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B1: Advances in Automated Inspection (Session 1 of 3) 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. |
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13:30 | Demonstrating Equivalent or Better Performance: Defending Qualification of AVI 13:50 | State of the Art Visual Inspection Using Machine Learning 14:10 | Strategies for Integrating Deep Learning in Automated Vision Inspection |
15:00 – 15:45 | Refreshment Break and Poster Presentations in the Exhibit Hall
15:45 – 17:15 | Concurrent Sessions
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A2: Difficult to Inspect Products and Packages 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. |
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15:45 | Visual Inspection Approaches for Ophthalmic Solutions Packaged in Opaque and Semi-Transparent Containers 16:05 | Automatic Inspection of Media Fill Test Kit: Feasibility and Advantages 16:25 | Surrogate Use for Inspection Qualification: Opportunities and Risks |
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B2: Advances in Automated Inspection (Session 2 of 3) This session is a deep dive into AI 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. |
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15:45 | Presentation of Use Cases Using Deep Learning Models in AVI 16:05 | Automated Visual Inspection Based on Unsupervised Machine Learning 16:25 | Lessons Learned: From a Pilot Study to a Validated Deep Learning Algorithm in Production |
17:15 – 18:30 | Networking Reception in Exhibit Hall
TUESDAY, 18 APRIL
07:30 – 17:00 | Registration Open
07:30 – 08:30 | Continental Breakfast
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08:30 – 10:00 | P3: Particle Identification: Who are you and where did you come from? 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! |
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08:30 | Innovative Prototype for Visible Particle Detection, Characterization, and Chemical Identification in Closed Container 09:00 | How to Lose a Particle in 5 Ways |
10:00 – 10:45 | Refreshment Break and Poster Presentations in Exhibit Hall
10:45 – 12:15 | Concurrent Sessions
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A3: Container Closure Integrity Testing (CCIT) |
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10:45 | Impact of Primary Container Traceability on Visual Inspection and CCIT 11:05 | Next Level Automatic Visual Inspection with CCIT and Serialization 11:25 | High Voltage Leak Detection: An Invaluable Lab Tool for Assessing Container Closure System Compliance to Annex I and USP1207 |
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B3: Advances in Automated Inspection (Session 3 of 3) 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. |
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10:45 | Achieving Small False Positive Rate for Automated Visual Inspection via a Dual-Threshold Convolutional Neural Network 11:05 | Evolution of Particles and Cosmetic Validation Kits: What Would Be Their Future with the Arrival of Neural Networks? 11:25 | Using Deep Learning for Visual Inspection |
12:15 – 13:30 | Networking Lunch with Exhibitors
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13:30 – 15:00 | P4: Designing Your Visual Inspection Program |
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13:30 | Optimizing the Visual Inspection Organization 14:00 | How to Establish a Companywide Effective Visual Inspection Program and Lifecycle Particle Control Strategy |
15:00 – 15:45 | Refreshment Break and Poster Presentations in the Exhibit Hall
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15:45 – 16:45 | P5: Ask the Experts: An Interactive Panel Discussion 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! |
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16:45 | Closing Remarks from Forum Co-Chairs John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC Romain Veillon, PharmD, Director Vision Technology, GSK Vaccines |
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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
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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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GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
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We're currently finalizing our list of sponsors and will share the details shortly.
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