The implementation of a robust quality management system will improve the quality and consistency of CMC review and enhance the efficiency of ONDQA’s review processes. <br>This key project has been retired as CDER has created new measures and key projects for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research. </b> ON TRACKON TRACK1. Document and catalog existing Office processes6/30/2010Completed6/10/20102. Review existing CDER MAPPs and Office procedures10/1/2010Completed11/29/20103. Perform Gap Analysis10/1/2010Completed10/1/20104. Identify need for office procedures and MAPPs (1)6/30/2011 <i>(9/1/2011)<i><i>(11/1/2011)<i>Completed12/15/20115. Develop new MAPPs and office procedures12/23/2011Completed12/23/20116. Train employees on new procedures3/31/2012Completed12/23/20117. Establish Methodology to evaluate performance and capability of office procedures9/30/2012On Track(1) Completion of this key project is dependent on completion of the quality manual which is currently an ongoing effort.The dates in italics under the milestone due dates are revised milestone due dates which were updated.http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Dashboard ਍††਍਍਍਍਍਍਍