HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-06-07

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

June 7, 2010

Attendees:

Norman Gregory (CVM), David Longstaff (CVM), Tena Wei (CDRH), JoAnn Ziyad (CFSAN), Berhane Girmay (CFSAN), Catherine Hosage-Norman (Sepracor), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Jennifer Rice (Alpharma), Leon Hughes (Guident), Vija Kumar (Guident), Sridhar Vempati (Guident), Bob Boeri (Guident) and James Lee (Guident)

• We need to know why there were changes in the schema from release 1 to release 2 (xs:element name change from "ingredient" to "ingredientSubstnace" for specifiedIngredient, from from "ingredient" to "ingredientManufacturedMaterial" for batchIngredient and Substance reads "<xs:attribute name="determinerCode" type="EntityDeterminer" use="optional" fixed="EntityDeterminer"/>" and it was "<xs:attribute name="determinerCode" type="EntityDeterminer" use="required" />"). Is this something that changed at a higher level and trickled down? I will send an e-mail to find out what is happening.
• Looked at the IG and changes made to date, replaced "eStability" with "Drug Stability Reporting (eStability)" at it's first occurrence.
• Mike Yang will work on the examples form the first pilot (e.g., Genzyme) and try to get them in line with the release 2 schema.
• Catherine Hosage will work on making an example of multiple different types of tests for a mock product (an unrealistic product but would cover many different examples in one file.).
• I will work on getting the information from the Input Tool User Guide (examples) and putting them in the IG.
• We had people listening in from CFSAN and Guident to get an idea on how we are handling our IG and related issues.

Agenda for June 14, 2010 Teleconference:

• We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/).
• Work on IG.