The Standards Coordinating Body (SCB), with co-sponsorship from NIST, BioFabUSA, and NIIMBL, would like to invite key stakeholders from industry, regulatory and academic institutions to attend a workshop focused on rapid microbial testing methods (RMTM) in Rockville, Maryland at the National Cybersecurity Center of Excellence (NCCoE), on April 10, 2018.
The RMTM workshop will review existing technologies and associated standards/regulatory guidance, survey a selection of existing analytic technologies that could be adapted to cell therapy as well as next-generation devices and technologies to fill current gaps and significantly reduce processing and release times. The workshop will also provide an opportunity to personally contribute to the future focus of standards development in this area.
The current schedule of events includes:
- Workshop registration and breakfast (8:00 – 8:30 AM)
- Welcome and introductions (8:30 AM)
- Overview of current methodologies (Speaker: Spencer Hoover, CCRM)
- Review of standards and reference materials (Speaker: Scott Jackson, NIST)
- Overview of FDA Guidance (Speaker: FDA representative TBD)
- Panel discussion on current methodological gaps
- Roundtable discussion: Building user requirement specifications (URS) for new technologies
- Rapid presentations of applicable technologies
- Review of URS exercise, discussion of overall strategy, and next steps
- Close of meeting and departure (5:00 PM)
Registration for this initial event is limited to 70 participants (please limit to two attendees from your organization).