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U.S. Department of Health and Human Services

About FDA

Public Workshop on “Statistical Process Controls for Blood Establishments

Description: 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. Information current as of September 30, 2012.

Public Health Outcome: 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.

Accomplishment: 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

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Identify Co-Sponsors


Completed 2/27/2012

B. Identify Planning Committee


Completed 4/5/2012

C. Develop Agenda


Completed 5/1/2012

D. Confirm speakers



Completed 7/18/2012

E. Issue Federal Register notice



Completed 8/2/2012

F. Hold workshop and simultaneous webinar


Completed 10/19/2012

G. Evaluate workshop and plan next steps


Completed 11/1/2012

H. Post transcripts on FDA website


Completed 11/2/2012

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.


Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.