HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-02-22

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

February 22, 2010

Attendees:

Norman Gregory (CVM), Elizabeth Cormier (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Edward Pec (Abbott Laboratories), and Jennifer Rice (Alpharma)

  • Component5 from "StabilityStudy" should be 1..1 StudyOnBatch, not 1..*, need to change the message and IG. The message should generate one report for a single storage condition of a single lot number.
  • For the Product/Substance tab of Input Tool the Status field should be bold red if FDA radio button is select under options.
  • Message needs a way to capture Study number (new attribute for StabilityStudy), can ID be 1 to many (1..*) or an alias attribute.
  • Have the stylesheet display container information with breaks.
  • Please start trying to use the Input Tool and document any issues. It can be found at https://www.estability.org then click on wiki at top of page and it is at the bottom, file name SMIT-0950.zip and the expiration is 3/1/2010. The first time opening will ask for license key that is provided on the wiki. There is also a Word file ”input_tool_observations” that documents other known issues. You need Microsoft.NET framework, version 2 or higher (most current is 3.5) for the Input Tool to work.

Agenda for March 1, 2010 Teleconference: