HL7 Stability Standard Implementation Guide Teleconference Minutes 2011-03-14

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

March 14, 2011

Attendees:

Norman Gregory (CVM), Elizabeth Cormier (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sunovion), Mike Mlodzik (Fort Dodge Animal Health), Mike Yang (ScienTek Software), Diane Miller(Alpharma), Chuck Warner (Beckloff Associates), and Sandra Spiewak (Reed Technology and Information Services Inc.)

  • Rearranged the IG getting the elements in the proper heading of "Simple Children" and "Complex Children".
  • Checked that all bookmarks in IG are working.
  • The Validation Document does have capTypeCode listed.
  • Updated the "Reason for Data File" in Code Lists (p. 59-60) with the different types of filings to FDA.
  • Updated the "Storage Condition Code" in Code lists (p. 68-69) and liked to the ICH and WHO documents.
  • The attached file (http://gforge.hl7.org/gf/download/docmanfileversion/6191/8142/eStability_Implementationguide_1_7_draft_3-14-11.zip) is the new version of the IG (1.7) in draft to be balloted for the May 2011 HL7 meeting, save file and change extension from .piz to .zip.

Agenda for March 21, 2011 Teleconference: