PDA Metro Chapter: CCIT Full Day Event
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Please join us at our exciting Container Closure Integrity Day! The event will take place on March 13th where industry experts will delve into the critical realm of Container Closure Integrity (CCI) for the pharmaceutical sector. Explore the dynamic landscape of regulatory shifts impacting parenteral package formats, including IV bags, vials, pre-filled syringes, cartridges, ampoules, and combination devices.
Our event aims to address the challenges in dissecting information and identifying the most suitable methods for your parenteral drug product. Discover solutions that help assess, evaluate, and mitigate risks associated with container-closure systems. Gain insights into effective product lifecycle management strategies, ensuring both product quality and patient safety.
Additionally, deterministic Container Closure Integrity Testing (CCIT) are currently used in the pharmaceutical and biopharmaceutical industries to:
- Characterize and understand Maximum Allowable Leakage Limit (MALL)
- Screen and select optimal as well as compatible container components for package development
- Understand Container Closure Integrity (CCI) of new package/container formats undergoing cold and ultra-cold storage conditions in real-time
- Proactively prevent package integrity recalls – mitigate package integrity risks
Don't miss this opportunity to stay at the forefront of advancements in Container Closure Integrity. Join us for informative presentations and discussions that promise to enhance your understanding of this critical aspect of pharmaceutical manufacturing.
We are excited to see you in person at the Olde Mill Inn, Basking Ridge, NJ!
The Olde Mill Inn has a hotel on the property for those seeking convenient accommodation.
Contact
Chapter Inquiries
Membership Services
Late Registration after March 8th
Member Price
$300.00Non-Member
$400.00
Day 1
8:30am - 9:30am | Continental Breakfast, Registration & Vendor Show
9:30am - 9:45am | Welcome & Announcements, PDA Metro Chapter/PTI/Wilco
9:50am - 10:15am | Regulatory Landscape - Focus on Americas, Oliver Stauffer, PTI
10:20am - 10:45am | Regulatory Landscape – Focus Europe, Matthias Hiddemann, Wilco (remote)
10:50am - 11:20am | Differential Pressure & Headspace Analysis, Dr. Matthias Kahl, Wilco (remote)
11:25am - 11:55am | Microcurrent HVLD & Helium Mass Spectroscopy, Mike DeVito, PTI
12:00pm - 1:00pm | Lunch/Group Pictures
1:05pm - 1:25pm | Solution Design – a structured approach to minimize the risks within CCIT (and AVI) inspection projects, Matthias Hiddemann, Wilco (remote)
1:30pm - 1:50pm | Container Closure Risk Assessment for Sterile Injectables, Tyler Harris, PTI
1:55pm - 2:15pm | CCI role in Product Lifecycle - Differential Pressure & Headspace Analysis, Dr. Matthias Kahl, Wilco (remote)
2:20pm - 2:40pm | CCI role in Product Lifecycle - Microcurrent HVLD & Helium Mass Spectroscopy, Tyler Harris, PTI
2:45pm - 2:55pm | Afternoon Break
3:00pm - 3:30pm | CCI Industry Perspective & Use, Jessica Hankins and Matt Kisielius, BMS
3:35pm - 3:50pm | Panel Discussion, Wilco / PTI / BMS
3:55pm - 4:00pm | Prizes, Closing Remarks, PDA Metro Chapter
* Timing may shift accordingly
Featured Presenters
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Mike DeVito
Regional Sales Engineer, PTI
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Mike DeVito
PTI
Mike received his Bachelor of Chemical Engineering degree with a minor in Sustainable Energy Technology from the University of Delaware. He joined PTI in 2022 as a Regional Sales Engineer, responsible for the account management, development, and support of the Life Science business segments. His experience and areas of expertise span a variety of enabling technologies and analytical methodologies deployed in the R&D, process development, and manufacturing environments. They include in-situ spectroscopic and particle size Process Analytical Technologies (PAT), automated chemical synthesis, and deterministic Container Closure Integrity Testing (CCIT) solutions.
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Tyler Harris
Business Development Application Engineering Manager, PTI
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Tyler Harris
PTI
Tyler is a graduate of Virginia Tech with a B.S. in Packaging Systems and Design. His background and expertise are in packaging, mechanical design, and quality engineering. Since joining PTI in October of 2020 as an Application Engineer, Tyler has specialized in non-destructive, Deterministic CCI Test methods ranging from Airborne Ultrasound to Vacuum Decay and MicroCurrent HVLD, focusing on applications in the Medical Device and Pharmaceutical industries. Tyler’s current position is Business Development Applications Engineering Manager. Tyler is also an active IOPP member and active ASTM F02 committee collaborator.
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Matthias Hiddemann
Technical Product Manager, WILCO AG
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Matthias Hiddemann
WILCO AG
Matthias got a mechanical diploma degree at the University of Dortmund (Germany) and a diploma degree in economics at the University of Bochum (Germany). He started his industry career as a project manager within the plant engineering and construction industry. Throughout his career he gained more than 20 years of experience in sales, marketing, and product management withing the machinery industry in regulated environments. Since 2021 Matthias is with WILCO – in his current position he is the Technical Product Manager with a focus on Container Closure Integrity Testing (CCIT).
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Matthias Kahl
Head of R&D and Lab Services, WILCO AG
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Matthias Kahl
WILCO AG
Dr. Matthias Kahl has been Head of the Research, Development and Laboratory Services of WILCO AG in Wohlen since 2018. He started in 2017 as responsible for development of new technologies. After studying physics at the University of Erlangen in the field of solid state physics and physical metrology, he obtained his doctorate in modern optics and laser technology at the University of Konstanz in 2006. This was followed by a position as deputy development manager in the field of high-precision material processing with lasers. Further tasks include innovation management, intellectual property issues, and collaboration in quality management. -
Oliver P. Stauffer
CEO, PTI
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Oliver P. Stauffer
PTI
Oliver Stauffer received his Bachelors of Science degree from the University of Michigan and completed his MBA at Georgetown University. He began his career in analytical and R & D laboratories, with a focus on sensory technologies, physio-chemical measurement and test method development specific to package testing. Stauffer joined PTI in 2005 as a member of the research and development team working on non-destructive testing of high-risk pharmaceutical packaging. In 2006, he joined the sales team as applications engineer for PTI Inspection Systems. He held the position of International Business Development Manager for PTI through 2010, followed by COO through 2015, focusing on global quality solutions for package inspection that provide the highest level of measurement accuracy and reliability. During his time with PTI he has developed several technology platforms, measurement methodologies, and technology patents. In 2016, he was appointed as CEO.
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The Olde Mill Inn has an on-site hotel for those seeking convenient accommodation.