Join us and your peers to continue the dialog on medical device sterilization science and take a deeper dive to understand how to utilize new radiation modalities.
Overview: On September 21, 22, and 23, 2022 the Organizing Committee of the Medical Device Sterilization Workshop will host a virtual workshop for stakeholders exploring sterilization alternatives using accelerator-based radiation.
The workshops will run from:
- 8:30 am CDT to 12:00 pm - Wednesday, September 21st
- 8:30 am CDT to 12:00 pm - Thursday, September 22nd
- 8:30 am CDT to 11:45 pm - Friday, September 23rd
REGISTRATION DEADLINE: September 7, 2022
Over three half-days, the workshop will build on the work presented in the past three years (summary reports) and work towards fostering collaboration and partnership under the common goal of patient safety:
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A mock Pre-submission interaction with the FDA
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Emerging modeling and simulation tools to help you better utilize radiation on your products.
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A panel discussion with members from the bio-processing industry illustrating how industry cooperation can smooth the regulatory process
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There will be multiple Q&A opportunities to provide interaction and to allow you to present your experiences and confront your uncertainties.
Connection information will be e-mailed to registrants 24 hours prior to the event.
Invited Speakers
Keynote presentation – Aftin Ross (FDA), confirmed
- Ryan Ortega, FDA – leading the Mock Pre-submission, confirmed
- PNNL/Team Nablo
- Vu Le, Abbott
- James McCoy, BD
- Daniel Badali, Triple Ring Technologies
- TRAD
Organizing Committee
- Debbie Cotton (Retired)
- Thomas Kroc (Fermilab)
- Vu Le (Abbott)
- Mark Pasmore (Baxter)
- John Williams (Medtronic)
Who should attend: Recent events in the medical device sterilization community reinforce that patient safety, in particular sterility assurance, is not specific to any particular company, vendor, or institution. This forum seeks to bring together voices from across these various organizations to define and build the future of this industry, for the benefit of the patients we serve. Participants from technical, business, and regulatory functions from the following organization types will benefit from workshop participation:
- Medical device manufacturers
- Accelerator manufacturers
- Contract sterilization vendors
- Medical device regulators
- Medical device regulatory
- Medical device and sterilization laboratories
Attendees should expect to:
- Examine the current science of radiation sterilization techniques (X-ray, gamma, and E-beam)
- Maintain connection with developments in the use of alternative technologies for medical device sterilization
- Influence discussion on the direction of medical device sterilization and potential collaboration opportunities and mechanisms to help realize that future
- Interact with staff of the FDA to better understand how to work with the FDA for approvals for new and existing products