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HL7 Stability Standard Implementation Guide Teleconference Minutes 2012-07-16

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

July 16, 2012

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman, Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Edward Pec (Abbott Laboratories), and Art Griesser (Promethues)

  • Correction to 7/9/12 minutes, bullet two, “It appears that if you list something as a BatchIngredient the HL7 schema is requiring all the information for it as if it was a ManufacturedMaterial. This is not what was intended. The BatchIngredient was to capture the formulation and is optional and should only need the ingredient and the quantity.” The batch record can be captured with batchIngredient, the formulation is captured with specifiedIngredient. There are ways you can omit the information being asked with batchIngredient and still have a valid xml file.
  • Clarification to 7/9/12 minutes, bullet four, “In the IG after the major Header “SpecifiedIngredient” we need another major header “ingredentSubstance”, (it is a complex child of SpecifiedIngredient)”. We cannot replace Substance with ingredientSubstance, the ingredientSubstance is a Substance data type playing a different role. Substance is used if the stability report is for an API, ingredientSubstance is used if the stability report is for a Product and you capture the API being used.
  • VB.NET Form: Instead of choosing a screen resolution the screen can be stretch and font size changed.
  • VB.NET Form: Can save associated studies.
  • VB.NET Form: Can auto generate results (allows pre-population of Test Name, Test Site), Data Type and Unit are pre-populated from Specification.
  • VB.NET Form: Can flush instance specific data.
  • VB.NET Form: Only mandatory fields will have an asterisk (*).
  • VB.NET Form: Check mandatory fields will be under utilities.
  • VB.NET Form: Can save double data entry to a separate file.
  • VB.NET Form: What you pick with code allows what you can choose for null value.
  • VB.NET Form: Preview has a refresh button.
  • There will be no teleconference on July 23, 2012.

Agenda for July 30, 2012 Teleconference: