SPADA Working Groups ~ April Meeting Book

on to “Validation Guidance,” where the word “roughly” was removed and SEC was clarified include to SEC 1, SEC 2, and SEC 3. The group agreed that this assay needs to be specific to SEA-C and does not detect D and onwards. Witzenberger highlighted that SEE is one of the stronger cross reactions there is, although it is very rare. IV. Adjourn The meeting adjourned at 3:00 p.m. EST and the group agreed to meet again on March 25 at 2:00 p.m. EDT.

MARCH 4, 2015 SPADA SEB WG MEETING: ACTION ITEMS

Action

Owner

Schedule follow up call or March 25. Incorporate today’s changes into SMPR

AOAC

AOAC / Tallent