[Federal Register Volume 77, Number 149 (Thursday, August 2, 2012)]
[Notices]
[Pages 46096-46097]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18854]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No.FDA-2012-N-0001]
Statistical Process Controls for Blood Establishments; Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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The Food and Drug Administration (FDA) is announcing a public
workshop entitled: ``Statistical Process Controls for Blood
Establishments.'' The purpose of this public workshop is to discuss the
implementation of statistical process controls to validate and monitor
manufacturing processes in blood establishments. The public workshop
has been planned in partnership with the AABB, America's Blood Centers,
and the Department of Health and Human Services (HHS) Office of the
Assistant Secretary for Health. The public workshop will include
presentations and discussions led by experts from government and
industry.
Dates and Times: The public workshop will be held on October 19,
2012, from 8:30 a.m. to 5 p.m.
Location: The public workshop will be held at the FDA White Oak
Campus, The Great Room, Bldg. 31, 10903 New Hampshire Ave. Silver
Spring, MD, 20993. Please visit the following Web site for location,
parking, security, and travel information: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. The public workshop will also be available to be viewed
online via webcast.
Streaming Webcast of the Public Workshop: For those unable to
attend in person, FDA will webcast the public workshop. To join the
web-cast of the public workshop, please go to: https://collaboration.fda.gov/stat101912/.
If you have never attended a Connect Pro meeting before: Test your
connection: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. Get a quick overview: http://www.adobe.com/go/connectpro_overview.
Contact Person: Jennifer Scharpf, Center for Biologics Evaluation
and Research (HFM-302), Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6128, FAX: 301-827-
2843, email: CBEROBRRWorkshops@fda.hhs.gov.
Registration: Mail, fax, or email your registration information
(including name, title, firm name, address, telephone and fax numbers,
and email address) to Jennifer Scharpf (see Contact Person) by
September 27, 2012. Please indicate if you will attend the workshop in
person or if you will participate in the webcast. There is no
registration fee for the public workshop. Early registration is
recommended because seating is limited. Those who wish to present at
the workshop must attend in person. Registration on the day of the
public workshop will be provided on a space-available basis beginning
at 7:30 a.m.
If you need special accommodations due to a disability, please
contact Jennifer Scharpf (see Contact Person) at least 7 days in
advance.
Requests for Oral Presentations: Interested persons are invited to
make presentations relevant to the public workshop topic. Attendees who
wish to make presentations at the public workshop should notify the
Contact Person and submit a brief statement of the general nature of
the presentation before September 27, 2012. Presentations will be
scheduled on the afternoon of October 19, 2012. Time allotted for each
presentation may be limited depending on the number of individuals
requesting to speak.
[[Page 46097]]
SUPPLEMENTARY INFORMATION: Statistical process control is the
application of statistical methods to the monitoring, or quality
control, of a manufacturing process. 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.
Millions of units of Whole Blood and blood components, including
those collected by apheresis, are manufactured in the United States
annually. Blood establishments manufacture these products in accordance
with specific standards established by FDA regulations and guidance, as
well as in accordance with specifications established by device
manufacturers and industry standards. To ensure that product standards
are met, blood establishments validate manufacturing processes at
implementation and then monitor these processes on a regular basis,
using quality control methods.
Manufacturing biologic products, including Whole Blood and blood
components, comes with specific challenges due to biologic variability
and the potential risk to recipients if products are not manufactured
appropriately. Recognizing these issues, FDA has developed statistical
plans that are capable of identifying when the manufacturing process
varies or has a high frequency of nonconformance.
The goal of the workshop is to educate participants on statistical
process control theory and options for the implementation of
scientifically sound sampling plans in blood establishments. The public
workshop will include presentations and discussions on the following
topics: (1) The evolution of statistical process control for Whole
Blood and blood components; (2) statistical methods used for biologic
product quality control; (3) FDA considerations for sampling plans for
blood establishments; and (4) industry perspectives and case studies on
implementing statistical process controls.
Transcripts: Please be advised that a transcript of the public
workshop will be posted as soon as possible on the Internet at: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.
Transcripts of the public workshop may also be requested in writing
from the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Rockville, MD 20857.
Dated: July 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18854 Filed 8-1-12; 8:45 am]
BILLING CODE 4160-01-P