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HL7 Stability Standard Implementation Guide Teleconference Minutes 2011-09-12

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

September 12, 2011

Attendees:

Norman Gregory (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tena Wei (CDRH), Catherine Hosage-Norman (Sunovion), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Art Griesser (Promethues) and Howard Shatz (Data Conversion Laboratory, Inc.)

  • There is a new version of the schematron.
  • The validator could be giving errors for storage conditions.
  • Need to test the Product code field (page 23-24 IG and Section 3.5.2.3 of HL7 Drug Stability Reporting Validation Procedures document)
  • For example in the BatchIngredient (page 42-43 of IG) we need the code and code system for container and cap type.
  • I sent Mead Walker an e-mail asking him to be on the call next week to disuse Section 2.1 of the HL7 Drug Stability Reporting Validation Procedures document.
  • I sent an e-mail to the SPL address asking about the postal code validation list (Section 3.7.3.5 of attached HL7 Drug Stability Reporting Validation Procedures document).
  • The attached file (http://gforge.hl7.org/gf/download/docmanfileversion/6442/8687/eStability_Implementationguide_1_8_draft_9-12-11.zip) is the new version of the IG (1.8 draft (9-12-11)) with the changes (so far) based on the 9/12/11 teleconference, save file and change extension from .piz to .zip. Please take a final look for discussion.
  • The attachedfile (http://gforge.hl7.org/gf/download/docmanfileversion/6443/8688/HL7DrugStabilityReportingValidationProcedures9-12-11.zip) is the new version of the HL7 Drug Stability Reporting Validation Procedures document (9-12-11) with the changes, save file and change extension from .piz to .zip. Please take a final look for discussion.

Agenda for September 19, 2011 Teleconference:

  • We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/)
  • Final changes to IG
  • Schematron progress update
  • eStabilty Validation Procedures document
  • Outstanding issues
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