The objective of this workshop is to discuss statistical process controls for Whole Blood and blood products for both validation and monitoring (quality control) of manufacturing processes to ensure quality blood products and protect public health. <i>Information current as of September 30, 2012</i>. This workshop contributes to public heath as an educational forum for discussion of statistical process control theory and options on how to implement in statistical sampling plans in blood establishments. The public workshop will include presentations and discussions on the following topics: (1) educational presentation on current considerations in OBRR on SPC and validation and monitoring (quality control) recommendations; (2) educational program on basic statistics methods used for biologic product quality control; and (3) industry perspective on how to implement plans including their concerns and options. On October 19, 2012, OBRR held a public workshop on Statistical Process Controls for Blood Establishments. The purpose of this public workshop was to discuss the implementation of statistical process controls to validate and monitor manufacturing processes in blood establishments. The implementation of acceptable statistical process controls ensures that a process performs predictably to manufacture a product that meets specific standards. FDA monitors manufacturing procedures, validation summaries, and quality control data prior to licensure and during periodic inspection of facilities. The workshop was held at the White Oak Campus and also webcast to approximately 120 participants; enthusiastically received by participants as evidenced by the results of a post workshop survey. It is anticipated that the implementation of statistical process controls by blood establishments will further improve the safety and quality of blood products. The transcripts for the workshop can be viewed at the following URL: http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/UCM330333.pdf A. Identify Co-Sponsors 4/1/2012 Completed 2/27/2012 B. Identify Planning Committee 4/15/2012 Completed 4/5/2012 C. Develop Agenda 5/15/2012 Completed 5/1/2012 D. Confirm speakers 6/15/2012 <i>(8/15/2012)</i> Completed 7/18/2012 E. Issue Federal Register notice 7/1/2012 <i>(8/15/2012)</i> Completed 8/2/2012 F. Hold workshop and simultaneous webinar 10/19/2012 Completed 10/19/2012 G. Evaluate workshop and plan next steps 11/15/2012 Completed 11/1/2012 H. Post transcripts on FDA website 11/30/2012 Completed 11/2/2012 / http://www.fda.gov/AboutFDA/Transparency/track/ucm206349.htm FDA-TRACK CBER Research and Review Offices Dashboard ਍††਍਍਍਍਍਍਍