Public Workshop
Blood Establishment Computer Software
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.
Location
Hilton Washington, DC/Silver Spring
8727 Colesville Road
Silver Spring, MD 20910
Registration
Mail or fax your registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by June 20, 2008. Information regarding registration fees and online registration can be found at http://www.americasblood.org.
(FDA has verified the Web site, but we are not responsible for any subsequent changes to the Web site after this document posts on FDA’s Web site.)
Special accommodations
If you need special accommodations due to a disability, please contact Lori Beaston (see Contact Person) at least 7 days in advance.
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.
Transcripts
Transcripts of the public workshop may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page. A transcript of the public workshop will be available on the Internet at http://www.fda.gov/cber/minutes/workshop-min.htm.