[Federal Register Volume 70, Number 234 (Wednesday, December 7, 2005)]
[Notices]
[Pages 72844-72845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-23677]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Risk Management, Corrective and Preventive Actions, and Training: 
An Educational Forum; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory 
Affairs, Southwest Region, Dallas District Office, in collaboration 
with the FDA Medical Device Industry Coalition (FMDIC) is announcing a 
public workshop entitled ``Risk Management, Corrective and Preventive 
Actions, and Training: An Educational Forum.'' This public workshop is 
intended to provide information about FDA's medical device quality 
systems regulation (QSR) to regulated industry, particularly small 
businesses.
    Date and Time: The public workshop will be held on April 28, 2006, 
from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at The Westin City 
Center, 650 North Pearl St., Dallas, TX 75201. Directions to the 
facility are available at the FMDIC Web site at http://www.fmdic.org/.
    Contact Person: David Arvelo or Cassandra Davis, Food and Drug 
Administration, 4040 North Central Expressway, suite 900, Dallas, TX 
75204, 214-253-4952 or 214-253-4951, FAX: 214-253-4970, e-mail 
[email protected].
    Registration: FMDIC has a $150 early registration fee. Early 
registration begins on February 1, 2006, and ends April 14, 2006. 
Registration is $175 from April 15, 2006, to April 28, 2006. To 
register online, please visit http://www.fmdic.org/. As an alternative, 
you may send registration information including name, title, firm name, 
address, telephone and fax numbers, and e-mail, along with a check or 
money order for the appropriate amount payable to the FMDIC, to Dr. 
William Hyman, Texas A&M University, Department of Biomedical 
Engineering, 3120 TAMU, College Station, TX 75843-3120. Course space 
will be filled in order of receipt of registration with appropriate 
fees. Seats are limited; please submit registration form as soon as 
possible. Those accepted into the course will receive confirmation. 
Registration will close after the course is filled. Registration at the 
site will be done on a space-available basis on the day of the public 
workshop beginning at 8 a.m. The cost of registration at the site is 
$175 payable to the FMDIC. The registration fee will be used to offset 
expenses of hosting the conference, including meals, refreshments, 
meeting rooms, and materials.
    If you need special accommodations due to a disability, please 
contact David Arvelo or Cassandra Davis at least 7 days in advance.

SUPPLEMENTARY INFORMATION: The workshop is being held in response to 
the interest in the topics discussed from small medical device 
manufacturers in the Dallas District area. FMDIC and FDA present this 
workshop to help achieve objectives set forth in section 406 of the 
Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), 
which include working closely with stakeholders and maximizing the 
availability and clarity of information to stakeholders and the public. 
This is also consistent with the purposes of FDA's Regional Small 
Business Program, which are, in part, to respond to industry inquiries, 
develop educational materials, and sponsor workshops and conferences to 
provide firms, particularly small businesses, with firsthand working 
knowledge of FDA's requirements and compliance policies. This workshop 
is also consistent with the Small Business Regulatory Enforcement 
Fairness Act of 1996 (Public Law 104-121), as an outreach activity by 
Government agencies to small businesses.
    The goal of the workshop is to present information that will enable 
manufacturers and regulated industry to better comply with the medical 
device QSR. The following topics will be discussed at the workshop: (1) 
Overview of the International Organization for Standardization (ISO) 
standard EN 14971, and residual risk, (2) incorporating risk management 
throughout the product lifecycle, (3) overview of a closed-loop 
corrective and preventive action (CAPA) system, (4) CAPA effectiveness, 
(5) overview of a training program, and (6) training program 
effectiveness.
    Transcripts: Transcripts of the public workshop will not be 
available due to the format of this workshop. Course handouts may be 
requested in writing from the Freedom of Information Office (HFI-35), 
Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, 
MD 20857, approximately 15 working days after the public workshop at a 
cost of 10 cents per page.


[[Page 72845]]


    Dated: November 30, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-23677 Filed 12-6-05; 8:45 am]
BILLING CODE 4160-01-S