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IR-4 PMC Meeting

IR-4 PMC Meeting IR-4 HQ Princeton, NJ October 26, 2009 Tammy W. Barkalow RQAP-GLP IR-4 Assistant Director HQ QA. The IR-4 QAU: An Overview. Overview EPA Inspections Update –2009 Fall QA meeting – Agenda Audits and Inspections. IR-4 QAU UPDATE. US EPA Inspections 2009, update

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IR-4 PMC Meeting

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  1. IR-4 PMC Meeting IR-4 HQPrinceton, NJOctober 26, 2009Tammy W. Barkalow RQAP-GLPIR-4 Assistant Director HQ QA The IR-4 QAU: An Overview

  2. Overview EPA Inspections Update –2009 Fall QA meeting – Agenda Audits and Inspections IR-4 QAU UPDATE

  3. US EPA Inspections 2009, update North Carolina State, R. Batts September 21-24, 2009 Failure to notify IR4 of all studies Follow up with F. Liem’s office No findings, great job by Mr. Batts, Ms. Knight, and Ms. Forder Rutgers Ag. Exp. Station, Cream Ridge, Tom Freiberger Oct. 27-30, 2009 Under discussion, can it be postponed The IR-4 QAU: An Overview

  4. Fall QA Meeting at IR-4 HQ Agenda Review of All Hands meeting Review of the final report submission spreadsheet for 2009 and 2010 Review of the new IR-4 database and its new components Training and update on the revised QA Sops and their distribution for satellite or contract QA Review of the 2009 field season, lessons learned and needs identified Special projects – mosquito study potato post harvest fumigation SO2 Discussions on: Routing of QA audit reports via email systems (procedures to put into place to include expected printouts to be filed, wording of email body, nomenclature for naming audit files, persons to send audit to (FRD and their regional QA coordinator, etc.), number of audits accepted per email, etc)  Protocol wording covering calibration acceptance criteria Changes made to the 2010 protocol and FDB Add study completion date (tie in to database dates) Experimental termination date to reflect GLP definition Other changed sections Lessons learned from S. Benzen’s GLP statements and how the new statement is being used.  Develop consensus on expectations for final reports. Bracketing of scales used for field test substances and language in the FDB Facility inspection follow up, update on length of inspection to report, responses status Legibility of ASRs and final reports The IR-4 QAU: An Overview

  5. Audits and Inspections FDBs 2007 - 6 remain, 4 with WSR QA, 2 with HQ QA 2008 – 41 in QA, 39 to come to QA, 472 complete 2009 – 55 in QA, 505 to come to QA Final Report and Field Data Book audit progress: The IR-4 QAU: An Overview

  6. QA Resources Audits of 2008 FDBs 2008 FDBs Done In QA expected Total HQ 165 14 11 190 NCR 74 5 1 80 NER 78 6 12 96 SOR 101 7 7 115 WSR 54 9 8 71 Total 472 41 39 552 The IR-4 QAU: An Overview

  7. QA Resources Audits of 2009 FDBs 2009 FDBs Done In QA expected Total HQ 3 25 178 206 NCR 0 9 95 104 NER 0 0 3 3 SOR 7 6 128 141 WSR 0 15 99 114 Total 10 55 503 568 The IR-4 QAU: An Overview

  8. QA Final report audits tracking, 10/13/09 In QA currently Done in 09 HQ 4 13 NCR 2 2 NER 0 9 SOR 3 8 WSR 0 16 Total 9 48 The IR-4 HQ QAU has 11final reports for 2nd check and has completed 56 2nd checks this year. HQ has audited and finalized 6 Amended Final Reports in 2009. The IR-4 QAU: An Overview

  9. Thank You The IR-4 QAU: An Overview

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