Global Quality Systems-An Integrated Approach To Improving Medical Product Safety; Public Workshop, 10181 [2013-03323]
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Federal Register / Vol. 78, No. 30 / Wednesday, February 13, 2013 / Notices
• User experience and evaluation of
current processes and tools and their
effects on organizational performance;
• Needs and specifications for
proposed new tools and processes;
• Business processes driving the
development of information systems;
and
• The effect of processes and tools on
problem solving quality, efficiency, and
cost.
All abstracts must be received by
February 15, 2013, and authors whose
posters have been accepted will be
notified by February 28, 2013.
The conference will make available an
exhibition hall. The exhibitor price for
this conference is $3,500. Neither
PhUSE nor FDA endorse any
commercial software or vendor.
Dated: February 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–03324 Filed 2–12–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.
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 tollfree 800–533–0127; https://
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
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:21 Feb 12, 2013
Jkt 229001
10181
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.
• Nanotechnology.
• 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 Basis.
• 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
COST OF REGISTRATION
of FDA-regulated drugs and devices.
Member .........................................
$450.00 The workshop helps to achieve
Non-Member .................................
$550.00 objectives set forth in section 406 of the
To be added to registration fee for
Food and Drug Administration
registration postmarked after
Modernization Act of 1997 (Pub. L. 105–
May 14, 2013 ............................
$100.00 115) (21 U.S.C. 393), which includes
working closely with stakeholders and
If you need special accommodations
maximizing the availability and clarity
due to a disability, please contact
of information to stakeholders and the
Krystal Reed (see FOR FURTHER
public. The workshop also is consistent
INFORMATION CONTACT) at least 21 days in
with the Small Business Regulatory
advance of the workshop.
Enforcement Fairness Act of 1996 (Pub.
Registration instructions: To register,
L. 104–121), as outreach activities by
please complete and submit an AFDO
Government Agencies to small
Conference Registration Form, along
businesses.
with a check or money order payable to
Dated: February 8, 2013.
‘‘AFDO.’’ Please mail your completed
registration form and payment to:
Leslie Kux,
AFDO, 2550 Kingston Rd., suite 311,
Assistant Commissioner for Policy.
York, PA 17402. To register online,
[FR Doc. 2013–03323 Filed 2–12–13; 8:45 am]
please visit https://www.afdo.org/
BILLING CODE 4160–01–P
conference. (FDA has verified the Web
site address, but is not responsible for
subsequent changes to the Web site after DEPARTMENT OF HEALTH AND
this document publishes in the Federal
HUMAN SERVICES
Register.)
The registrar will also accept payment Food and Drug Administration
through Visa and MasterCard credit
[Docket No. FDA–2011–N–0724]
cards. For more information on the
public workshop, or for questions about Documents To Support Submission of
registration, please contact AFDO at
an Electronic Common Technical
717–757–2888, FAX: 717–650–3650, or
Document; Availability
email: afdo@afdo.org
The public workshop helps fulfill the AGENCY: Food and Drug Administration,
Department of Health and Human
HHS.
Services’ and FDA’s important mission
ACTION: Notice.
to protect the public health. The
workshop will provide FDA-regulated
SUMMARY: The Food and Drug
drug and device entities with
Administration (FDA) is announcing the
information on a number of topics
availability of the following revised
concerning FDA requirements related to final versions of documents that support
the production and marketing of drugs
making regulatory submissions in
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:
kreed@afdo.org.
SUPPLEMENTARY INFORMATION:
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:
PO 00000
Frm 00055
Fmt 4703
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]]>Agencies
[Federal Register Volume 78, Number 30 (Wednesday, February 13, 2013)]
[Notices]
[Page 10181]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03323]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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; https://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: kreed@afdo.org.
SUPPLEMENTARY INFORMATION:
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 https://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
Register.)
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: afdo@afdo.org
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.
Nanotechnology.
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
Basis.
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]
BILLING CODE 4160-01-P
