2020 PDA Europe Virtual Conference - Visual Inspection Forum
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Program Highlights
The 2020 PDA Europe Visual Inspection Forum will focus on Innovations in Automated Visual Inspection! Join the discussions around new developments in inspection hardware and software, the associated validation strategies as well as the specific regulatory and practical considerations for an effective inspection of the growing number of Cell & Gene Therapy products.
Learn the most recent updates to the European Pharmacopoeia and hear the French Inspectorate ANSM share their main findings regarding visual inspection!
Dear Colleagues,
On behalf of the Scientific Program Planning Committee and PDA Europe, we would like to invite you to the Visual Inspection Forum to take place on 19-20 October 2020.
This forum will provide a platform to present and discuss new developments in the field of visual inspection. This year we will have a special focus on the use of automated visual inspection technology to meet this critical process need. Discussion will include both the inspection hardware and software along with the validation strategies necessary to deploy this technology.
We will also cover the emergence of Deep Learning and key concept associated to this step change like data flow and data integrity. We will also address manual inspection which continues to be the reference method for visual inspection. Also, the holistic VI process will be covered with discussions on control strategies such as AQL and defect trending. 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. On 20 December 2017, the long-awaited revision to Annex 1 of the EU GMP Guidelines was published. While the currently valid Annex 1 only briefly touches on the important topics of container closure integrity control and visual inspection, this revision contains significantly expanded requirements. The new requirements encourage further discussion of the correct understanding and implementation of visual inspection within the pharmaceutical manufacturing supply chain and provide only one of this year‘s hot topics.
We anticipate a strong agenda of knowledgeable experts in this field along with an exhibition of the latest commercial inspection technology and services.
We look forward to seeing you take part in the 2020 Visual Inspection Forum!
Sincerely,
The Co-Chairs
John Shabushnig, PhD, Insight Pharma Consulting
Romain Veillon, GSK
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Standard Pricing
Standard Member Price
€1.795GovernmentMember Only
€900
Health AuthorityMember Only
€900
Early Career ProfessionalMember Only
€900
AcademicMember Only
€900
Non-Member
€2.095
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Day 1
Monday, 19 October 2020
9:00
Welcome and Introduction
Falk Klar, PDA Europe
John Shabushnig, Insight Pharma Consulting, Conference Chair
Romain Veillon, GSK Vaccines, Conference Chair
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Opening Plenary: Regulatory Updates |
| Visual Inspection of parenteral drug products is a highly regulated activity by Pharmacopeia’s and Health Agencies. This forum will start with a session dedicated to regulatory updates. First, inspection citations and findings will be presented from the perspective of the French Authorities. Then, last updates from both USP and EDQM pharmacopoeias will be presented. |
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09:15 09:45 10:45 |
11:15 - 11:45
Coffee Break, Poster Session & Exhibition
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Session 1: Particles & Particle Identification |
| Understanding the source and composition of particulate matter provides the necessary substrate for the development of adequate control strategies and comprehensive risk assessments. This session will discuss the development and use of analytical methods to further characterize and subsequently classify particles in injectables. A comprehensive overview on the PDA's Zero Visible Defects Project shows the complexity of particle sources and approaches for the reduction of the particle load in the manufacturing environment. A novel approach to determine the identity of particles will be also part of this session. |
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11:45 12:15 12:45 |
13:15 - 14:15
Lunch Break, Poster Session & Exhibition
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Session 2: Inspection of Cell Therapy Products and other Difficult to Inspect Products |
| Whereas the majority of drug products in the meantime are inspectable with well-established techniques, a number of products remain difficult to inspect. This session illustrates the challenges and progress for two types of such products. In addition, an excursion is made to the visual inspection challenges for single-use assemblies in the drug manufacturing process. |
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14:15 14:40 15:05 15:30 |
15:45 - 16:15
Coffee Break, Poster Session & Exhibition
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Session 3: Updates in Automated Visual Inspection |
| Difficult to inspect products can take advantage of latest available technologies and processing concepts to improve the detectability of foreign particulate critical for patient safety. Flexible containers as well as turbid media nowadays have become inspectable thanks to high-resolution sensors and artificial intelligence advanced concepts. It is anyway paramount to develop a proper design of equipment to assess the risks in terms also of occurrence and detectability to not sacrifice productivity and putting in place an effective control strategy to keep under control the risks that even the latest technology cannot mitigate. |
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16:15 16:40 17:05 17:30 |
18:00
End of Conference Day 1 & Networking Event
Day 2
Tuesday, 20 October2020
9:00
Welcome
John Shabushnig, Insight Pharma Consulting
Romain Veillon, GSK Vaccines
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Session 4: Deep Learning & Artificial Intelligence |
| In the years to come, Deep Learning will be a major change for automated visual inspection. This session will cover those changes from the perspectives of regulatory guidance, technology development, validation approaches and new developments in capabilities. After an interactive questionnaire, the new PDA Task Force working on Deep Learning will be showcased. Multiple case studies will be presented to cover process design, validation and false reject reduction. To conclude, a panel discussion will allow rich exchanges on Deep Learning deployment. |
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09:05
09:15 09:45 |
10:15 - 10:45
Coffee Break, Poster Session & Exhibition
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Session 5: Deep Learning & Artificial Intelligence, con't |
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10:45 11:10 11:35 |
12:10 - 13:10
Lunch Break, Poster Session & Exhibition
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Session 6: Inspection Standards and their Use in Manual Visual Inspection |
| Well-designed and well-maintained reference standard kits for particles and defects are essential to perform successful inspection operations. Attendees will receive an overview of the complex process of developing a reference standard kit with examples given on the most commonly used containers. Also, an approach to a Probability of Detection Study will be shared. It will be discussed how the findings impact the strategy for Visual Inspection Qualification. |
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13:00 13:30 14:00 |
14:30 - 15:00
Coffee Break, Poster Session & Exhibition
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Closing: Qualification Aspects of VI Technology |
| This session was designed to address practical considerations faced by those who work in the field of visual inspection and stimulate discussion on future directions to improve inspection results. Validation is required and critical to the successful implementation of AVI. False rejects are a concern with all VI methods and impact both cost and yield as well as confidence in the inspection results. |
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15:00 15:30 |
16:00
Conference Summaries by the Chairs
John Shabushnig, Insight Pharma Consulting
Romain Veillon, GSK Vaccines
16:30
Closing Remarks & Farewell
Falk Klar, PDA Europe
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