2011-23747. 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: [phone].

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: [phone]; e-mail: [e-mail].

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:

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: [phone], e-mail: [e-mail].

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.