HL7 Stability Standard Implementation Guide Teleconference Minutes 2017-10-16

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HL7 Stability Standard Teleconference Minutes

October 16, 2017

Attendees: Norman Gregory (CVM), Time Lee (CBER), Catherine Hosage-Norman (Module 3 Solutions, LLC), and Tammy Wright (Dechra)

  • In SPL for the NDC code value that they use both the eight-digit code (0001-0001), which is at the product level and the ten-digit code (0001-0001-01) which is at the packaged level. We might have to allow for the use of both, for a stability study it is usually at a packaged level (ten-digit code), but for a photostability study it is at the product level (eight-digit code).
  • We did not have enough principles at the meeting to talk about the validation document.
  • We will continue to use the audio on the WebEx.

Agenda for October 23, 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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