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

Attendees:

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.

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