HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-03-09

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

March 9, 2009


Norman Gregory (CVM), Terry Hardin (Perfitech), Jonathan Cook (CDER), Tena Wei (CDRH), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Diane Miller (Alpharma), and Holly Settles (Elanco)

  • If there is more than one manufacturing site, another Manufacturing Site: field is added. Can this be done?
  • Need to document differences in XML tags and style sheet (e.g., sponsor = manufacturer).
  • Style sheet transform code to value in another field, especially for container/closure.
  • Field for capacity quantity (size of container)
  • Headings color coded for mandatory, required and, optional. Not sure this is needed for the style sheet as much as for an input tool (XForm)
  • The Drug Substance: field and Drug Substance Manufacturing Sites and Lot(s)/Batch(es): field need clear examples of what we want there.

Agenda for March 16, 2009 Teleconference:

  • Discuss the style sheet example, need to give input back to Catherine.