Document ID: FDA-2010-N-0001-0091
Agency: fda
Document Type: Notice
Title: Meetings: Quality and Compliance in Merging and Emerging Cultures; Public Conference
Posted Date: 2010-08-23T04:00Z

[Federal Register: August 23, 2010 (Volume 75, Number 162)]
[Notices]               
[Page 51825-51826]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23au10-80]                         

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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: 
info@pda.org.
    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
------------------------------------------------------------------------

    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