2010-20844. Quality and Compliance in Merging and Emerging Cultures; Public Conference

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public conference.

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: [phone].

Contact: Wanda Neal, Parenteral Drug Association, PDA Global Headquarters, Bethesda Towers, 4350 East-West Hwy., suite 200, Bethesda, MD 20814, 301-656-5900, FAX: [phone], email: [e-mail].

Accommodations: Attendees are responsible for their own 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

Affiliation	Fee
PDA Members	$1850
PDA Non-Members	$2099
Government	$700
PDA Member Academic/Health Authority	$700
PDA Non-Member Academic/Health Authority	$800
PDA Member Students	$280
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.