Document ID: FDA-2010-N-0142-0001
Agency: fda
Document Type: Notice
Title: Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum
Posted Date: 2010-04-09T04:00Z

[Federal Register: April 9, 2010 (Volume 75, Number 68)]
[Notices]               
[Page 18219]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ap10-106]                         

[[Page 18219]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0142]

 
Drug and Medical Device Forum on Food and Drug Administration 
Drug and Device Requirements and Supplier Controls; Public Educational 
Forum

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public educational forum.

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SUMMARY: The Food and Drug Administration (FDA) Baltimore District, in 
co-sponsorship with the Association of Food and Drug Officials (AFDO), 
is announcing a public educational forum entitled ``Drugs & Medical 
Device Supplier Management Forum.'' This 2-day public educational 
forum, a component of AFDO's Annual Educational Conference, is intended 
to provide information about FDA drug and device regulation to the 
regulated industry.
    Date and Time: The public educational forum will be held on Monday, 
June 21, 2010, from 8 a.m. to 5 p.m. and Tuesday, June 22, 2010, from 8 
a.m. to 5 p.m.
    Location: The public educational forum will be held at the Sheraton 
Norfolk Waterside Hotel, 777 Waterside Dr., Norfolk, VA 23510, 800-325-
3535, or 757-622-6664, FAX: 757-625-8271.
    Attendees are responsible for their own accommodations. To make 
reservations at the reduced conference rate, contact the Sheraton 
Norfolk Waterside Hotel before May 21, 2010, citing meeting code ``AFDO 
Conference''.
    Contact: Evelyn Bonnin, Food and Drug Administration, 6000 Metro 
Dr., suite 101, Baltimore, MD 21215, 410-779-5424, FAX: 410-779-5707, 
e-mail: Evelyn.Bonnin@fda.hhs.gov.
    Registration: You are encouraged to register by May 25, 2010. The 
AFDO registration fees cover the cost of facilities, materials, and 
breaks. Seats are limited; please submit your registration as soon as 
possible. Course space will be filled in order of receipt of 
registration. Those accepted into the course will receive confirmation. 
Registration will close after the course is filled. Registration at the 
site is not guaranteed but may be possible on a space available basis 
on the day of the public educational forum beginning at 7:30 a.m. The 
cost of registration follows:

                          Cost of Registration
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                    Affiliation                              Fee
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Government (AFDO/Central Atlantic State             $395.00
 Association (CASA) Member)
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Government (Non-Member)                             $495.00
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Non-Government (AFDO/CASA Member)                   $395.00
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Non-Government (Non-Member)                         $495.00
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To be added to registration fee for event           $75.00
 registration postmarked after May 26,2010
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    If you need special accommodations due to a disability, please 
contact Evelyn Bonnin at least 7 days in advance of the educational 
forum.
    Registration instructions: To register, please complete a 
Conference Registration Form with your name, affiliation, mailing 
address, phone, fax number, and e-mail, along with a check or money 
order payable to ``AFDO''. Please mail your payment to: AFDO, 2550 
Kingston Rd., suite 311, York, PA 17402. The registration form is 
available at http://www.afdo.org. (FDA has verified the Web site 
address, but is not responsible for subsequent changes to the Web site 
after this document publishes in the Federal Register).
    The registrar will also accept payment by major credit cards (VISA/
MasterCard only). For more information on the meeting, or for questions 
on registration, contact AFDO, 717-757-2888, FAX: 717-650-3650, or e-
mail: afdo@afdo.org.

SUPPLEMENTARY INFORMATION: The public educational forum helps fulfill 
the Department of Health and Human Services' and FDA's important 
mission to protect the public health. The educational forum will 
provide FDA-regulated drug and device entities with information on a 
number of topics concerning FDA requirements related to the production 
and marketing of drugs and/or devices. Topics for discussion include 
the following:
    Regulating Medical Products in the Global Environment
    FDA Revitalization Efforts--Top 10 Drug & Device 483 Observations
    FDA's Expectations for Supplier Controls
    FDA Import District Activities--Monitoring Foreign Drug and Device 
Suppliers
    Do's and Don'ts for Implementing Effective Quality Agreements
    Case Studies--Supplier Controls
    Supplier Quality in a Global Economy--Consensus Standards
    Inspectorate, Health Canada
    Building an Effective Supplier Control Program
    FDA's International Posts--Update on Activities and Future Plans
    FDA Recalls--A Focus on Supplier-Related Incidents & Other 
Compliance Initiatives
    Supplier Auditing--Tools of the Trade
    FDA has made education of the drug and device manufacturing 
community a high priority to help ensure the quality of FDA-regulated 
drugs and devices. The educational forum helps to achieve objectives 
set forth in section 406 of the Food and Drug Administration 
Modernization Act of 1997 (21 U.S.C. 393) which includes working 
closely with stakeholders and maximizing the availability and clarity 
of information to stakeholders and the public. The educational forum 
also is consistent with the Small Business Regulatory Enforcement 
Fairness Act of 1996 (Public Law 104-121), as outreach activities by 
Government agencies to small businesses.

    Dated: April 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8087 Filed 4-8-10; 8:45 am]
BILLING CODE 4160-01-S