[Federal Register Volume 78, Number 30 (Wednesday, February 13, 2013)]
[Page 10181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03323]



Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Global Quality Systems--An Integrated Approach To Improving 
Medical Product Safety; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.


SUMMARY: The Food and Drug Administration (FDA) Cincinnati District 
Office, in cosponsorship with the Association of Food and Drug 
Officials (AFDO), is announcing a public workshop entitled ``Global 
Quality Systems--An Integrated Approach to Improving Medical Product 
Safety.'' This 2-day public workshop is intended to provide information 
about FDA drug and device regulation to the regulated industry.

DATES: The public workshop will be held on June 10 and 11, 2013, from 8 
a.m. to 5 p.m.

ADDRESSES: The public workshop will be held at the Louisville Marriott 
Downtown, 280 West Jefferson St., Louisville, KY, 502-627-5045 or toll-
free 800-533-0127; http://www.marriottlouisville.com/.
    Attendees are responsible for their own accommodations. To make 
reservations at the Louisville Marriott Downtown, at the reduced 
conference rate, contact the Louisville Marriott Downtown before May 2, 
2013, and cite meeting code ``AFDO Conference.''

FOR FURTHER INFORMATION CONTACT: Krystal Reed, Association of Food and 
Drug Officials, 2550 Kingston Rd., suite 311, York, PA 17402, 717-757-
2888, FAX: 717-650-3650, email: [email protected].

    Registration: You are encouraged to register by May 14, 2013. The 
AFDO registration fees cover the cost of facilities, materials, and 
breaks. Seats are limited; therefore, 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 workshop beginning at 7:30 a.m. The cost of 
registration is as follows:

                          Cost of Registration
Member.......................................................    $450.00
Non-Member...................................................    $550.00
To be added to registration fee for registration postmarked      $100.00
 after May 14, 2013..........................................

    If you need special accommodations due to a disability, please 
contact Krystal Reed (see FOR FURTHER INFORMATION CONTACT) at least 21 
days in advance of the workshop.
    Registration instructions: To register, please complete and submit 
an AFDO Conference Registration Form, along with a check or money order 
payable to ``AFDO.'' Please mail your completed registration form and 
payment to: AFDO, 2550 Kingston Rd., suite 311, York, PA 17402. To 
register online, please visit http://www.afdo.org/conference. (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 
    The registrar will also accept payment through Visa and MasterCard 
credit cards. For more information on the public workshop, or for 
questions about registration, please contact AFDO at 717-757-2888, FAX: 
717-650-3650, or email: [email protected]
    The public workshop helps fulfill the Department of Health and 
Human Services' and FDA's important mission to protect the public 
health. The workshop 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:
     Future of Combination Product Regulation.
     Unique Device Identifier Progress.
     Health Canada Update.
     The Safety of our Drugs and Devices--the Complex Reality.
     Drug and Medical Device Trends.
     Case for Quality (Center for Devices and Radiological 
Health) Presented by Steve Silverman.
     Working Luncheon Interactive Session--Lessons Learned From 
the Mistakes of Others.
     Complaint Handling--It's Not Just About Compliance--It's 
an Effective Business Driver.
     FDA's Cosmetic Regulatory Agenda.
     Challenges With Implementation of U.S.P. 35 on a Global 
     Pilot Program for Abbreviated Drug Inspections.
    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 workshop helps to achieve objectives set forth 
in section 406 of the Food and Drug Administration Modernization Act of 
1997 (Pub. L. 105-115) (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 workshop also is 
consistent with the Small Business Regulatory Enforcement Fairness Act 
of 1996 (Pub. L. 104-121), as outreach activities by Government 
Agencies to small businesses.

    Dated: February 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03323 Filed 2-12-13; 8:45 am]