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:
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:
A mock Pre-submission interaction with the FDA
Emerging modeling and simulation tools to help you better utilize radiation on your products.
A panel discussion with members from the bio-processing industry illustrating how industry cooperation can smooth the regulatory process
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.
Keynote presentation – Aftin Ross (FDA), confirmed
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:
Attendees should expect to: