International Conference on Harmonisation Q10 Pharmaceutical Quality System; Meetings:
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
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.
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
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
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
BILLING CODE 4160-01-P
