PDA Metro Chapter: CCIT Full Day Event

13 Mar 2024
Basking Ridge, NJ

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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.

Agenda

Discover What's Happening Each Day
Wed 13 Mar
Wednesday, 13 March

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

Location and Travel

Venue Details and Accommodations

PLEASE 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.

The Olde Mill Inn has an on-site hotel for those seeking convenient accommodation.

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