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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Public Workshop: America's Blood Centers: Blood Establishment Computer Software (BECS) Conference

Transcripts

July 10, 2008
8:00 a.m. - 5:00 p.m.

July 11, 2008
8:00 a.m. - 12:30 p.m.

Workshop Goals and Objectives

The Food and Drug Administration (FDA) in co-sponsorship with America’s Blood Centers is announcing a public workshop entitled: Blood Establishment Computer Software. The purpose of the public workshop is to examine information technology issues at blood facilities in order to keep blood centers at the forefront of technology while assuring the continued safety and quality of the blood supply.

Blood establishment computer software (BECS) is designed to receive, store and process data used by blood establishments during the manufacturing process of blood products. The software capabilities range from determining donor eligibility through component processing, testing and labeling to product release. The workshop will consist of a series of presentations from experts representing blood and other drug industries, software companies and regulators from various countries. Breakout sessions will address a series of questions that are intended to generate information for enhancing BECS regulation and oversight. The workshop participants will examine information technology capabilities in blood and other drug manufacturing facilities and explore the current and anticipated future BECS functionalities. Current validation requirements for BECS and unique characteristics of blood establishments will be discussed. Specific topics to be discussed include: 1) history of BECS regulation in the United States, the 510(k) review process, and FDA inspection and adverse event reporting observations; 2) system and software choices; 3) the United States blood industry’s experience with BECS; and 4) advantages and disadvantages to software developers of entering the transfusion software market.

Contact

Lori Beaston
America’s Blood Centers
725 15th St NW, Suite 700
Washington, DC 20005
202-654-2901
Fax: 202-393-1282
email: lbeaston@americasblood.org.