HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-02-09

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

February 9, 2009

Attendees:

Norman Gregory (CVM), Terry Hardin (Perfitech), Mead Walker (Health Data & Interoperability Consulting), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Monica Mehta (Genzyme), Paul Tenaglia (Apotex), Lisa Ylitalo (Eleos), Edward Pec (Abbott Laboratories), Diane Miller (Alpharma), Holly Settles (Elanco), and Sandy Dinkens (Elanco)

• The tooling changed in HL7, model to schema dropped a step.
• PORT_HD09002uv, keep schema PORT_MT09001uv and PORT_MT09002UV. Mead will check with HL7 HQ.
• Input tool document v6.2.
• TestingSite need s to come from Testing and SiteStub from Test.
• Style sheet needs to be 501 compliant, limited use of colors.
• Style sheet can list an average value with the replicates in parenthesis, when you click the replicates you get the individual values with %RSD and average (e.g., 98.3% (3)). When you click the 3 you get a table of the three individual vales and the %RSD and average.

Pharmaceutical Industry and anyone else, we could use your in put regarding examples (case studies) of cycled studies (see below):

• We discussed having cycled studies examples (test cases) within one message (report). A cycled freeze/thaw study or stability of product after reconstitution (in use study) would be a separate message (report), not part of the same message. We need examples (case studies) of a product on stability and at a test station would have something else done to it and tested at an interval (e.g., sample is draw at 6 month test station and tested, then that same sample has something done and is tested at 1, 5 and 10 minutes).

Please give examples of the above

Agenda for February 23, 2009 Teleconference:

• No teleconference Monday February 16th.
• Continue discussion regarding the Input Tool Requirements document.
• Discuss the style sheet example.