HL7 Stability Standard Implementation Guide Teleconference Minutes 2011-12-05

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

December 5, 2011

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Tena Wei (CDRH), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Mike Yang (ScienTek Software), Art Griesser (Promethues), Sandra Spiewak (Reed Technology and Information Services Inc.), and April Daly (Lab Objects)

• Art talked with Josh about Section 3.21.4 of the HL7 Drug Stability Reporting Validation Procedures document, and Josh is looking into it.
• The FDA web page for eStability has been updated.
• The Bioinformatics Board (BiB) was replaced with the Interim Informatics Governance Board (iIGB).
• Everyone need to think about next steps and directions for the group. Get the word out to a wider audience like Pharmaceutical Stability Discussion Group (PSDG). Get an FDA Guidance published.

Agenda for December 12, 2011 Teleconference:

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