Document ID: FDA-2011-N-0002-0108
Agency: fda
Document Type: Notice
Title: International Conference on Harmonisation Q10 Pharmaceutical Quality System; Meetings: A Practical Approach to Effective Life-Cycle Implementation of Systems and Processes for Pharmaceutical Manufacturing
Posted Date: 2011-09-16T04:00Z

[Federal Register Volume 76, Number 180 (Friday, September 16, 2011)]
[Notices]
[Pages 57746-57747]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23747]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Conference on the International Conference on Harmonisation Q10 
Pharmaceutical Quality System: A Practical Approach to Effective Life-
Cycle Implementation of Systems and Processes for Pharmaceutical 
Manufacturing; Public Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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    The Food and Drug Administration (FDA), in cosponsorship with the 
Parenteral Drug Association (PDA), is announcing a public conference 
dedicated to teaching the principles of the International Conference on 
Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use (ICH) entitled ``Pharmaceutical Quality 
System (ICH Q10) Conference: A Practical Approach to Effective Life-
Cycle Implementation of Systems and Processes for Pharmaceutical 
Manufacturing.'' The conference will span 2-and-one-half days and will 
be a unique opportunity to learn the principles from companies that 
have implemented a Pharmaceutical Quality System across the product 
life cycle according to the ICH Q10 model. These companies are reaping 
the benefits that come from establishing and maintaining a state of 
control, continual improvement, enhancing regulatory compliance, and 
meeting quality objectives every day.
    Date and Time: The public conference, which will include an 
exhibition, will be held on Tuesday, October 4, 2011, from 8:30 a.m. to 
6:30 p.m.; Wednesday, October 5, 2011, from 8 a.m. to 5:30 p.m.; and 
Thursday, October 6, 2011, from 8 a.m. to 1 p.m.
    Location: The event will be held at the Crystal Gateway Marriott, 
1700 Jefferson Davis Hwy., Arlington, VA, 703-920-3230, Fax: 703-271-
5212.
    Contact Person: Wanda Neal, Parenteral Drug Association, PDA Global 
Headquarters, Bethesda Towers, 4350 East West Hwy., suite 200, 
Bethesda, MD 20814; 301-656-5900, ext. 111; Fax: 301-986-1093; e-mail: 
neal@pda.org.
    Attendees are responsible for their own accommodations. To make 
reservations at the reduced conference rate, contact the Marriott 
Crystal Gateway Hotel (see Location) and cite meeting code ``PDA.'' 
Room rates are single/double: $229.00, plus 10.5 percent State and 
local taxes. Reservations can be made on a space and rate available 
basis.
    Registration: You are encouraged to register at your earliest 
convenience. The PDA registration fees cover the cost of facilities, 
materials, and breaks. Seats are limited; please submit your 
registration as soon as possible. Conference space will be filled in 
order of receipt of registration. Those accepted into the conference 
will receive confirmation. Registration will close after the conference 
is filled. Onsite registration will be available on a space-available 
basis on the day of the public conference beginning at 7 a.m. on 
October 4, 2011.
    The cost of registration is as follows:

[[Page 57747]]

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PDA Members................................................    $1,695.00
PDA Nonmembers.............................................     1,944.00
Government/Health Authority Member.........................       700.00
Government/Health Authority Nonmember......................       700.00
PDA Member Academic........................................       700.00
PDA Nonmember Academic/Health Authority....................       780.00
PDA Member Students........................................       280.00
PDA Nonmember Students.....................................       310.00
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    If you need special accommodations due to a disability, please 
contact Wanda Neal, PDA (see Contact Person) at least 7 days in advance 
of the conference.
    Registration instructions: To register, please submit your name, 
affiliation, mailing address, telephone number, fax number, and e-mail 
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, http://www.pda.org/Q10. 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 
PDA, 301-656-5900, Fax: 301-986-1093, e-mail: info@pda.org.

SUPPLEMENTARY INFORMATION: While this conference is intended to explain 
the principles of ICH Q10, it is not a conference that only tells you 
what ICH Q10 says. It is an event where you can learn the 
practicalities of how to implement Q10 based on real-life case studies. 
The conference will draw on the best industry and regulator 
contributors on this topic from both the United States and Europe. It 
will show you how senior management commitment and involvement is 
vital.

    Dated: September 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23747 Filed 9-15-11; 8:45 am]
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