HL7 Stability Standard Implementation Guide Teleconference Minutes 2011-02-07

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

February 7, 2011

Attendees:

Norman Gregory (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sunovion), Mike Mlodzik (Fort Dodge Animal Health), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Diane Miller(Alpharma), Art Griesser (Promethues), and Sandra Spiewak (Reed Technology and Information Services Inc.)

  • A new version of the schematron has been posted, all the changes are internal.
  • The Outlook Mailbox with the name eStability@fda.hhs.gov to point to from our different document when needed has been created. The three people with access will be Norman Gregory, Elizabeth Cormier, and David Longstaff.
  • The site http://www.accessdata.fda.gov/stabilitydata was created. the Validation Document will point to htttp://www.accessdata.fda.gov/stabilitydata/stylesheet/eStability.xsl for the stylesheet and to http://www.accessdata.fda.gov/stabilitydata/schema/eStability.xsd for the schema.
  • We went over the Code Lists that was submitted for inclusion the NCI Thesaurus.
  • Attached is the validation document (HL7 Drug Stability Reporting Validation Procedures (2-7-11).doc) which was re-numbered and edits accepted up to Section 3.

Agenda for February 14, 2011 Teleconference: