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Standards Coordinating Body (SCB) with 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.
Agenda:
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8:00 am to 8:30 am |
Registration and Breakfast
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8:30 am to 8:45 am |
Welcome and General Introduction |
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8:45 am to 9:15 am |
Rodney Rietze, Novartis
Overview of Current Methodologies Spencer Hoover, CCRM
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9:15 am to 9:45 am |
Standards and Reference Materials Scott Jackson, NIST
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9:45 am to 10:15 am |
RMTM in Context of Current Sterility Regulations Richard McFarland, BioFabUSA
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10:15 am to 10:45 am |
Morning Coffee
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10:45 am to 11:30 am |
Panel Discussion: Identifying Gaps Bala Manian, LeukoDx, Inc Zorina Pitkin, Richard McFarland, BioFabUSA Jiwen Zhang, SCB John Duguid, Vericel
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11:30 am to 12:30 pm |
Roundtable Discussion: Technical Strategy Intro to discussion: Spencer Hoover, CCRM
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12:30 pm to 1:00 pm |
Lunch
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1:00 pm to 3:00 pm |
Technology Presentations Richard Hammond, Cambridge Consultants Damian Marshall, Cell and Gene Therapy Catapult Bala Manian, LeukoDx Inc Remy Cima, Promicol Monika Weber, Fluid-Screen Inc Anna Lau, NIH Kai Nesemann, Sartorius
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3:00 pm to 3:30 pm |
Afternoon Break
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3:30pm to 4:45pm |
Part 1: Roundtable Discussion of Draft URSs Based on technical strategy from AM discussion Part 2: Discussion on Delivery Strategy (next steps). Discussion lead: Richard McFarland, ARMI
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4:45pm to 5:15 pm |
Close of Meeting- Departure |
Registration for this initial event is limited to 70 participants (maximum two people from each organization).
If you are not registered, you will not be allowed on site. Registered attendees will receive security and campus instructions prior to the workshop.
NON U.S. CITIZENS PLEASE NOTE: All foreign national visitors who do not have permanent resident status and who wish to register for the above meeting must supply additional information. Failure to provide this information prior to arrival will result, at a minimum, in significant delays in entering the facility. Authority to gather this information is derived from United States Department of Commerce Department Administrative Order (DAO) number 207-12.
*New Visitor Access Requirement: Effective July 21, 2014, Under the REAL ID Act of 2005, agencies, including NIST, can only accept a state-issued driver’s license or identification card for access to federal facilities if issued by states that are REAL ID compliant or have an extension. As of Monday, January 30, 2017, Federal agencies will be prohibited from accepting driver’s licenses and identification cards from the following states for accessing federal facilities: Maine, Minnesota, Missouri, Montana and Washington. For further details, please visit our Campus Access and Security page.
Acceptable Photo Identification:
For Non-US Citizens: Valid passport for photo identification
For US Permanent Residents: Permanent Resident/Green card for photo identification