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

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

December 12, 2011

Attendees: Norman Gregory (CVM), Tena Wei (CDRH), Catherine Hosage-Norman (Sunovion), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Edward Pec (Abbott Laboratories), Art Griesser (Promethues), Sandra Spiewak (Reed Technology and Information Services Inc.), and Don Lloyd (HL7)

• Don Lloyd from HL7 has the new eStabiltiy information for the patch to the 2011 Normative Edition. The attached file (http://gforge.hl7.org/gf/download/docmanfileversion/6586/8941/patchV3_DSR_R2_Correction_2011DEC.zip) is the patchV3_DSR_R2_Correction_2011DEC, extract to a folder. Catherine is going to do a comparison to what Woody did to make sure there are no other changes.
• Art talked with Josh about Section 3.21.4 of the HL7 Drug Stability Reporting Validation Procedures document, and we changed the wording. See the attached file (http://gforge.hl7.org/gf/download/docmanfileversion/6587/8942/HL7DrugStabilityReportingValidationProcedures_Final12-12-11.zip) HL7 Drug Stability Reporting Validation Procedures_Final (12-12-11.)
• Catherine gave a talk at the 2nd Annual Forum on Stability Programs in Philadelphia "Laying the Groundwork for eStability". The talk was well received. About 80% of participants use LIMS and their hope is that the LIMS vendors will have their software get the information from the system.
• American Association of Pharmaceutical Scientist (AAPS) has different publications we could get an article into and an annual meeting someone could have a poster board session or give a talk at.

Agenda for December 19, 2011 Teleconference:

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