AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public conference.

SUMMARY:

The Food and Drug Administration (FDA), in cosponsorship with Parenteral Drug Association (PDA), is announcing a public conference entitled “Compliance Through Quality Systems: Implementing and Advancing a Sustainable Global Quality Culture.” The conference will cover current issues affecting the industry as well as explore strategies and approaches for ensuring conformance with regulations to facilitate the development and continuous improvement of safe and effective medical products. The conference establishes a unique forum to discuss the foundations, emerging technologies and innovations in regulatory science, as well as the current quality and compliance areas of concerns. Meeting participants will hear from FDA and industry speakers about the requirements and best practices to consider while implementing robust quality systems in order to deliver the best quality product.

Date and Time: The public conference will be held on September 10, 2012, from 7 a.m. to 6 p.m.; September 11, 2012, from 7:30 a.m. to 6:15 p.m.; and September 12, 2012, from 7:30 a.m. to 12:15 p.m.

Location: The public conference will be held at the Baltimore Marriott Waterfront Hotel, 700 Aliceanna St., Baltimore, MD 21202, 410-385-3000, Fax: 410-895-1900.

Contact: 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, email: info@pda.org.

Accommodations: Attendees are responsible for their own accommodations. To make reservations at the Baltimore Marriott Waterfront Hotel at the reduced conference rate, contact the Baltimore Marriott Waterfront Hotel (see Location)—cite the meeting code “PDA.” Room rates are: Single: $229, plus 15.5 percent state and local taxes and Double: $229, plus 15.5 percent 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 September 10, 2012. The cost of registration is as follows:

Please visit PDA's Web site: http://www.pda.org/​pdafda2012 to confirm the prevailing registration fees. (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 .)

If you need special accommodations due to a disability, please contact Wanda Neal (see Contact), 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 PDA's Web site: http://www.pda.org/​pdafda2012.

The registrar will also accept payment by major credit cards (VISA/American Express/MasterCard only). For more information on the meeting, or for questions on registration, contact 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 (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.