2021 PDA Visual Inspection Forum
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On behalf of the Program Planning Committee and PDA, we invite you to the 2021 PDA Visual Inspection Forum taking place on 14-15 April 2021. Visual inspection is critical to the manufacture and delivery of high-quality injectable medicines. The Forum provides a platform to present and discuss new developments in the field of VI. This year, we have a special focus on the use of automated visual inspection technology to meet critical inspection needs, especially when rapid scale-up in capacity is required. Discussion will include both the inspection hardware and software, including recent developments with artificial intelligence (AI) applications, along with the validation strategies necessary to deploy this technology.
As always, manual inspection remains an important tool 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. 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 will be covered. The regulatory and compendial requirements that govern the inspection process will also be discussed. New versions of USP <1790> and EU Annex 1 are expected in 2021, along with guidance from the FDA on visible particles. These new requirements encourage further discussion of the correct understanding and implementation of VI within the pharmaceutical manufacturing supply chain and provide another one of this year‘s hot topics.
We look forward to seeing you virtually for the 2021 PDA Visual Inspection Forum!
Sincerely,
The Co-Chairs
John G. Shabushnig, PhD, Insight Pharma ConsultingRomain Veillon, PharmD, GSK Vaccines
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
- Understand and implement a visual inspection lifecycle
Program Highlights
Agenda
Discover What's Happening Each Day
WEDNESDAY, 14 APRIL
09:00 – 10:00 | Virtual Exhibit Hall Open
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10:10 – 11:10 | Regulatory Overview Regulatory requirements are a major driving force for the development and implementation of appropriate visual inspection procedures. This session will provide an overview on visual inspection requirements; the current regulatory considerations; and the background and essential fundamentals of USP <790> criteria and <1790> guidance. |
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Welcome from Program Planning Committee Co-Chairs The Changing Visual Inspection Regulatory Environment Current Regulatory Considerations for the Assessment of Visible Particulates in Injectable Pharmaceuticals Panel Discussion and Q&A |
11:10 – 11:40 | Virtual Exhibit Hall Open
11:40 – 12:40 | Concurrent Sessions
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PROCESS TRACK |
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11:40 – 12:40 | A1: Particle Investigations Executing efficient and comprehensive particle investigations is critical in parenteral manufacturing. This session will provide an overview of particle investigation best practices as well as advanced particle identification techniques. |
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Particle Investigation Best Practice Identifying the Source of Particulate Matter in Injectables – A Case Study Panel Discussion and Q&A |
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TECHNOLOGY TRACK |
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11:40 – 12:40 | B1: Automated Inspection Case Studies The evolution of automated inspection assists in achieving increased productivity, accuracy, and consistency. This session highlights the practical aspect of automated inspection process. Multiple case studies related to automated inspection machines will be presented to cover process design and validation. |
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Accelerating the Inspection Journey from Feasibility to Vaccine Production: Case Study Qualification Comparison of a Deep Learning Automated Inspection Machine to Traditional Vision Automated Inspection Machine using KNAPP Methodology Panel Discussion and Q&A |
12:40 – 13:00 | Connect & Network and Tech Talk Video Chats
13:00 – 14:00 | Concurrent Sessions
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PROCESS TRACK |
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13:00 – 14:00 | A2: PDA Task Force Updates PDA has been actively supporting efforts to better understand and ultimately reduce the number of units rejected for visible particles. The papers in this session provide an update on current activities and recently published reports from two groups; one developing and assessing test methods for use with primary packaging components the other surveying current experience and practices with flexible containers. |
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Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers PDA Survey: Particulate Matter in Flexible Containers Panel Discussion and Q&A |
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TECHNOLOGY TRACK |
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13:00 – 14:00 | B2: Automated Inspection Recent developments in automated inspection can benefit to the patient with higher defect detection and lower false rejection rate. During AVI machine set-up phase, the opportunities and risks associated with surrogate testing will be explored. Also, the field for small scale AVI equipment will be discussed as Biopharmaceuticals are expanding. |
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Placebo vs. Real Product: Opportunities and Challenges during Machine Set-up New Requirements of the Inspection and Packaging Process for Small Batch Sized Medicines Panel Discussion and Q&A |
14:00 – 14:30 | Connect & Network and Tech Talk Video Chats
THURSDAY, 15 APRIL
09:00 – 10:00 | Virtual Exhibit Hall Open
10:00 – 11:00 | Concurrent Sessions
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PROCESS TRACK |
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10:00 – 11:00 | A3: Combination of AVI and Leak Detection Recent emphasis on container closure integrity (CCI) has driven interest in combining leak detection with the automated visual inspection process. This session includes examples of how leak detection technologies have been added to automated visual inspection platforms. |
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Automated Inspection of Vials with Lyophilisates Automated High Voltage Leak Detection Backed by Data Panel Discussion and Q&A |
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TECHNOLOGY TRACK |
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10:00 – 11:00 | B3: Artificial Intelligence (AI) in AVI #1 An introduction and recent developments in AI applied to AVI will be discussed. Topics of deep learning pitfalls to avoid and practical considerations for implementation will be covered. |
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PDA Task Force Point to Consider AI Applied to VI Unsupervised Anomaly Detection and Segmentation for Visual Inspection in Highly Optimized Manufacturing Processes Panel Discussion and Q&A |
11:00 – 11:30 | Virtual Exhibit Hall Open
11:30 – 12:30 | Concurrent Sessions
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PROCESS TRACK |
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11:30 – 12:30 | A4: Inspection Life Cycle and Process Design There are many practical considerations when implementing an effective visual inspection program. These talks address getting the most from the process and using it to drive defect reduction through continuous process improvement. They further address practical considerations when establishing process boundaries and appropriate qualification and validation strategies. |
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Quality Metrics and Data Integrity for VI, Particulate and Physical Defects in the 21st Century Bracketing Strategy Methodology Panel Discussion and Q&A |
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TECHNOLOGY TRACK |
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11:30 – 12:30 | B4: Artificial Intelligence (AI) in AVI #2 – Defect Classification and Trainings Sets The power of digitalization is shown everywhere in pharmaceutical industry. Using AI algorithms to enhance the automated visual inspection for difficult to inspect products is a powerful option. The classification of defects and the creation of trainings sets will be discussed and explained further. |
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AI Classification Used in Automated Visual Inspection of BFS Container – Aspects of Implementation and Validation Practical Guidance for Creating Supervised Learning Training Sets from Manually Labeled Automated Visual Inspection Images for Deep Learning Algorithm Development Panel Discussion and Q&A |
12:30 – 13:00 | Connect & Network and Tech Talk Video Chats
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13:00 – 14:15 | Panel Discussion and Forum Highlights Highlights from the two days Forum will be shared prior to a panel discussion. The panel discussion will include all of the organizing committee members, representing a wide cross-section of backgrounds and extensive industry experience. The session will allow for expanded discussion of topics presented at the Forum, and the panel will be responding to live questions from attendees. |
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Forum Highlights Panel Discussion Closing Remarks from Program Planning Commitee Co-Chairs |
Registration
Pricing Options
Standard Registration
Member Price
$1,117GovernmentMember Only
$490
Health AuthorityMember Only
$490
Early Career ProfessionalMember Only
$559
StudentMember Only
$196
AcademicMember Only
$490
Non-Member
$1,312
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.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to registration@pda.org.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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