PDA Visual Inspection Workshop 2024
Opportunities and Challenges for Difficult to Inspect Biologicals (ATMPs / CGT)
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Dear Colleagues,
Please be kindly invited to join this one-day workshop on visual inspection (VI) that will be held in Berlin, Germany on 03 December 2024.
This workshop is organized with the help of the PDA Visual Inspection Interest Group and will focus on current topics of practical interest to those responsible for VI in their companies or those who supply products or services in VI.
The agenda is designed to maximize discussion on hot topics related to visual inspection. Short expert presentations are provided to stimulate discussion followed by time for more extensive discussion. Participants can bring their relevant questions, challenges, and experience resulting in a diverse and practical exchange for each topic. This has proven very fruitful in the past and provides an opportunity to align the workshop with the specific interests of those who register and attend.
We have identified three topics for discussion this year:
- Difficult to Inspect Products (DIP), especially ATMP/CGT Therapies
- Challenges of Acceptance Sampling / AQL Inspection for Small Batches
- A3P Particle Interest Group Update and Current Activities of A3P on VI
Expert speakers include John Shabushnig, from Insight Pharma Consulting, and Romain Veillon, from GSK. Each will provide an overview of the current state of the art and then moderate a discussion to advance our understanding of the topic and practical use of available technologies.
This is a great opportunity to network and learn from experts and colleagues who share the same interests and challenges as you. You may also want to take advantage of the training course offered immediately following the Workshop in the same venue. Both PDA An Introduction to Visual Inspection: A Hands-On Course and PDA Mastering Automated Visual Inspection will be taught on the days following the workshop in the same venue.
We look forward to welcoming you to Berlin this fall!
Sincerely,
The Workshop Co-Leaders
John Shabushnig, Insight Pharma Consulting
Romain Veillon, GSK
SCIENTIFIC PROGRAM PLANNING COMMITTEE:
- John Shabushnig, Insight Pharma Consulting
- Romain Veillon, GSK
- Falk Klar, PDA
- Sabine Hartmann, Manager Programs & Events, PDA Europe
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Member Price
€ 580Non-Member
€ 580
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
Tuesday, 03 December 2024
09:30 | Welcome and Introduction
|
09:45 | Biological and Difficult to Inspect Products 10:00 | Automatic Visual Inspection of ATMPs and CGT: Challenges and Opportunities |
10:15 | Group Discussion |
10:45 - 11:15 | Coffee Break
11:15 | Continuing Group Discussions |
12:00 - 13:00 | Lunch Break
13:00 | Sampling Plan for Small Batch and Alternative Strategies |
13:15 | Group Discussion |
14:00 - 14:30 | Coffee Break
14:30 | A3P Particle Interest Group Update and Current Activities of A3P on VI 14:35 | Operator Qualification |
14:45 | Group Discussion |
15:30 | Summary of the Workshop and Take-Home Messages |
16:00 | End of Workshop and Farewell
The agenda is subject to change without notice. Speakers are invited pending confirmation.
Featured Presenters
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Massimo Frasson, MS
Brevetti C.E.A. Spa
Read BioMassimo Frasson, MS
Brevetti C.E.A. Spa
Mr. Massimo Frasson holds a Master's Degree in Mechanical Engineering and has a successful career in the automation industry. He began his journey with Brevetti C.E.A. in 2000 as the Mechanic Systems Design Manager and progressively assumed more significant roles. In 2007, he played a pivotal role in Brevetti C.E.A.'s restructuring and the introduction of new vision technologies. Simultaneously, he led a department focused on pharmaceutical process analysis using artificial vision systems and neural algorithms.
In 2010, Mr. Massimo Frasson took on the responsibility for the entire operations process and was appointed General Manager in February 2014. His leadership and dedication led to his promotion to CEO in 2019. Today, he continues to drive Brevetti C.E.A.'s growth and development with his extensive industry knowledge and commitment to excellence.
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Valerie Rautureau
Eli Lilly
Read BioValerie Rautureau
Eli Lilly
Valérie began her career at Eli Lilly in 1996, supporting the implementation of a biotechnology unit. She transitioned to Parenteral operations in 2000, ensuring support to manufacturing operations and operational team leading. During this time, she developed an in-depth knowledge of the different parenteral manufacturing steps and associated challenges.
From 2005 to 2015 she held different positions from project manager to product steward and second loop support to parenteral operations. She progressively developed competencies in visual inspection activities to become the Site visual inspection expert in 2015, covering inspection strategies evolution and global alignment. She moved to a global function in 2023, working on the implementation of new Site visual inspection strategies and global harmonization.
She started co-leading the visual inspection interest group in the A3P organization in 2020 and co-authored the team's 2 good practices guides.
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Elise Tourlet
UCB
Read BioElise Tourlet
UCB
Elise has been working in the pharma industry since 2018. She started in Project Management of technology transfer (filling, assembly, and packaging of injectable products) at Catalent Belgium and then moved on to Manufacturing Science and Technology in Visual Inspection and Packaging, working on alignment to standards and continuous improvement.
Interested in Visual Inspection, she started a new challenge as a Process Engineer Visual Inspection in Sterile Manufacturing at UCB in December 2023, working on the development of semi-automated visual inspection and optimization of manual visual inspection. Back in 2022, she joined the A3P organization, willing to learn and develop around experienced members.
Presenters
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John G. Shabushnig, PhD
Principal Consultant, Insight Pharma Consulting, LLC
John G. Shabushnig, PhD
Insight Pharma Consulting, LLC
John is the founder of Insight Pharma Consulting, providing expert guidance in visual inspection and particle control. He began his career with The Upjohn Company responsible for process analytical technology (PAT) and visual inspection. He was Director of Technical Support and Engineering for Pharmacia with responsibility for sterile and non-sterile technology transfer and process improvement, package engineering and automation. He later served as Director of the Center for Advanced Sterile Technology. Before starting his consulting firm, he managed microbiology and aseptic manufacturing technical support for Pfizer’s Global Quality Operations. John holds a B.S. in Chemistry from Carroll College and a Ph.D. in Analytical Chemistry from Indiana University. He is an active member of the Parenteral Drug Association, having served as chair of the Board of Directors and chair of the Science Advisory Board. He organized and co-leads the Visual Inspection Interest Group. He also instructs at PDA's Training and Research Institute. John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He has published and presented numerous papers on spectroscopic analysis, PAT, rapid microbiological testing and visual inspection of pharmaceutical products. He co-authored the recently published book Visual Inspection and Particulate Control. -
Romain Veillon
Director Vision Technology, GSK
Romain Veillon
GSK
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Request InformationPLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
INNSiDE by Meliá Berlin Mitte
Chausseestraße 33Berlin, Germany 10115, Germany
PDA recommends the reservation at the following hotel
INNSide by Meliá Berlin Mitte
Chausseestraße 33
10115 Berlin,
Germany
PDA Europe has reserved a limited number of rooms until 21 October 2024.
Book your room at the PDA Group Rate using the above-mentioned reservation button.
How to Get Here
Special Deutsche Bahn Train Fares
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Event Ticket one-way and specific train (subject to availability):
- 1st class 89,90€ (seat reservation incl.)
- 2nd class 55,90€
Event Ticket one-way and fully flexible:
- 1st class 112,90€ (seat reservation incl.)
- 2nd class 77,90€
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