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

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:

• We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/).
• Schematron progress update
• eStability Validation Procedures document.