HL7 Stability Standard Implementation Guide Teleconference Minutes 2017-10-30

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HL7 Stability Standard Teleconference Minutes

October 30, 2017

Attendees: Norman Gregory (CVM), Catherine Hosage-Norman (Module 3 Solutions, LLC), Art Griesser (Promethues), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), and Tammy Wright (Dechra)

  • Attached is a in progress version of the validation document (https://gforge.hl7.org/gf/project/rcrim/docman/eStability/eStability-validation-document-afg-10-30-2017.doc).
  • Section 3.5.2 will only use the 8-digit (2-segment) part of the code to identify the product since we get container/closure information in a different place.
  • Section 3.5.2.4 width is the time-period (e.g., 24 months) the use of low value means propose and the high value means approved and is a hard date (e.g., 20201115). We should revisit when we comply to PQ/CMC and try to use the unused date elements to make this clearer.
  • Section 3.6.1 CodeSystemName changed to “Unique Ingredient Identifier (UNII)”
  • We will continue to use the audio on the WebEx.

Agenda for November 6, 2017 Teleconference at 3:10 pm:

  • Continue working on updating the validation document.
  • We will be using WebEx for sharing documents and for audio. When the WebEx starts click the Audio and have it call you or it will give you a number to call 1-301-796-7777.

Meeting information


Topic: HL7 eStability Date: Every Monday, from Monday, September 18, 2017, to Monday, January 29, 2018 Time: 3:00 pm, Eastern Daylight Time (New York, GMT-04:00)

https://fda.webex.com/fda/j.php?MTID=m81cb3ee82e43ebf59caf0c732ab2f045

Meeting number: 749 065 873 Meeting password: vr3feZ82

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