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<key-projects><projects><title>Quality Assurance Program (Phase I)</title><description>Strengthen the quality assurance program for OBRR by developing a formal quality framework and developing written standard operating procedures according to a prioritized timeline.</description><dictionary></dictionary><outcome></outcome><accomplishment>In September 2009, OBRR established a Quality Assurance Program whose purpose was to strengthen a culture of quality for the office and mirror the requirements that are levied on CBER stakeholders.  The program included implementation and training of the OBRR Quality Manual and Quality Assurance Plan.  OBRR continues to develop over 45 standard operating procedures as part of the Quality Assurance Program.  OBRR anticipates a significant number of these standard operating procedures will be implemented in the next fiscal year, as well as the formalization of several internal metrics to monitor mission critical activities. The establishment of this program emphasizes our commitment to meeting the same quality standards to which our stakeholders are held.  The establishment of the Quality Assurance Program marks the completion of Phase I for this project.  Phase II of this project will build upon the foundation of Phase I and will begin in FY 2011.</accomplishment><table><title></title><row><type></type><milestone-description>A. Establish Quality Assurance Manual</milestone-description><milestone-date>5/1/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>4/19/2010</milestone-completion-date></row><row><type></type><milestone-description>B. Establish Quality Assurance Plan</milestone-description><milestone-date>5/1/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>4/19/2010</milestone-completion-date></row><row><type></type><milestone-description>C. Develop a list of priority OBRR office specific Standard Operating Procedures (SOPs) as part of the quality initiative</milestone-description><milestone-date>7/1/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>6/29/2010</milestone-completion-date></row><row><type></type><milestone-description>D. Complete Staff training on the Quality Assurance Manual</milestone-description><milestone-date>8/1/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>7/30/2010</milestone-completion-date></row><row><type></type><milestone-description>E. Complete Staff training on the Quality Assurance Plan</milestone-description><milestone-date>8/1/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>7/30/2010</milestone-completion-date></row><row><type></type><milestone-description>F. Draft first OBRR office specific SOP under the OBRR Quality Assurance Program</milestone-description><milestone-date>9/1/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>5/17/2010</milestone-completion-date></row><row><type></type><milestone-description>G. Finish first OBRR office specific SOP under the OBRR Quality Assurance Program</milestone-description><milestone-date>11/1/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>10/19/2010</milestone-completion-date></row><footnotes><note></note></footnotes></table></projects><glossary><word><text>Molecular Epidemiology</text><definition>Molecular epidemiology is a branch of medical science that focuses on the contribution of potential genetic and environmental risk factors, identified at the molecular level, to the etiology, distribution and prevention of disease within families and across populations.</definition></word></glossary><related-links><link><url>http://www.fda.gov/AboutFDA/Transparency/track/ucm206349.htm</url><text>FDA-TRACK CBER Research and Review Offices Dashboard</text></link></related-links></key-projects>
    






