[Federal Register Volume 75, Number 162 (Monday, August 23, 2010)]
[Notices]
[Pages 51825-51826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20844]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Quality and Compliance in Merging and Emerging Cultures; Public
Conference
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public conference.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
conference entitled ``The New Paradigm: Quality and Compliance in
Merging and Emerging Cultures.'' The conference, cosponsored with the
Parenteral Drug Association (PDA), will focus on challenges facing the
medical products industry in navigating regulatory compliance,
achieving worldwide quality improvement, and enhancing quality system
controls in an environment of merging and emerging cultures.
Date and Time: The public conference will be held on Monday,
September 13, 2010, from 7 a.m. to 6 p.m.; Tuesday, September 14, 2010,
from 7:30 a.m. to 6:30 p.m.; and Wednesday, September 15, 2010, from
7:30 a.m. to 12:15 p.m.
Location: The public conference will be held at the Renaissance
Hotel, 999 9th St., NW., Washington, DC 20001, 202-898-9000, FAX: 202-
289-0947.
Contact: Wanda Neal, Parenteral Drug Association, PDA Global
Headquarters, Bethesda Towers, 4350 East-West Hwy., suite 200,
Bethesda, MD 20814, 301-656-5900, FAX: 301-986-1093, email:
[email protected].
Accommodations: Attendees are responsible for their own
[[Page 51826]]
accommodations. To make reservations at the Renaissance Hotel at the
reduced conference rate, contact the Renaissance Hotel (see Location),
citing meeting code ``PDA.'' Room rates are: Single: $288, plus 14.5%
state and local taxes and Double: $288, plus 14.5 state and local
taxes. Reservations can be made on a space and rate availability basis.
Registration: Attendees are encouraged to register at their
earliest convenience. The PDA registration fees cover the cost of
facilities, materials, and refreshments. Seats are limited; please
submit your registration as soon as possible. Conference space will be
filled in order of receipt of registration. Those accepted for the
conference will receive confirmation. Registration will close after the
conference is filled. Onsite registration will be available on a space
available basis on each day of the public conference beginning at 7
a.m. on Monday, September 13, 2010. The cost of registration is as
follows:
Cost of Registration
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Affiliation Fee
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PDA Members $1850
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PDA Non-Members $2099
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Government $700
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PDA Member Academic/Health Authority $700
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PDA Non-Member Academic/Health Authority $800
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PDA Member Students $280
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Non-Member Students $310
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If you need special accommodations because of a disability, please
contact Wanda Neal, at least 7 days in advance of the conference.
Registration instructions: To register, please submit your name,
affiliation, mailing address, telephone, fax number, and email address,
along with a check or money order payable to ``PDA.'' Mail to: PDA,
Global Headquarters, Bethesda Towers, 4350 East West Hwy., suite 200,
Bethesda, MD 20814. To register via the Internet, go to the PDA Web
site, https://store.pda.org/events/registration/registration_start_choose_type. (FDA has verified the Web site address, but FDA is not
responsible for any 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 the PDA (see Contact).
Transcripts: As soon as a transcript is available, it can be
obtained in either hardcopy or on CD-ROM, after submission of a Freedom
of Information request. Written requests are to be sent to Division of
Freedom of Information (HFI-35), Office of Management Programs, Food
and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD
20857.
SUPPLEMENTARY INFORMATION: The PDA/FDA Joint Public Conference offers
the unique opportunity for participants to join FDA representatives and
industry experts in face-to-face dialogues. Each year, FDA speakers
provide updates on current efforts affecting the development of global
regulatory strategies, while industry professionals from some of
today's leading pharmaceutical companies present case studies on how
they employ global strategies in their daily processes.
Through a series of sessions and meetings, the conference will
provide participants with the opportunity to hear directly from FDA
experts and representatives of global regulatory authorities on best
practices, including:
Pharmaceutical Safety and Good Distribution Practices
Patient Requirements and Product Development
Quality Unit Responsibility
Continual Improvement
Technology Transfer
Supply Chain
Combination Products
Recall Root Causes
Biologics
Knowledge Management
Foreign Inspection Practices
Process Validation
Risk Management in Manufacturing
Change Control
Dated: August 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-20844 Filed 8-20-10; 8:45 am]
BILLING CODE 4160-01-S