United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2012_register executive 2012-08-07 article Notices D09002ee1c7fca068 D09002ee1c7fca0fa United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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: 77 FR 47078 https://www.govinfo.gov/app/details/FR-2012-08-07/2012-19295 2012-19295 fr07au12-71 4160-01-P Docket No. FDA-2012-N-0001 https://www.govinfo.gov/app/details/FR-2012-08-07/2012-19295 https://www.govinfo.gov/content/pkg/FR-2012-08-07/html/2012-19295.htm https://www.govinfo.gov/content/pkg/FR-2012-08-07/pdf/2012-19295.pdf 2 p. 47078 47079 77 FR 47078 2012 Parenteral Drug Association/Food and Drug Administration Joint Regulatory Conference; Compliance Through Quality Systems: Implementing and Advancing a Sustainable Global Quality Culture; Federal Register Vol. 77, Issue NOTICE 2012-19295 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2012-N-0001 4160-01-P 2012-19295 Notice of public conference.

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:

Public Conferences: Compliance Through Quality Systems; Implementing and Advancing Sustainable Global Quality Culture , info@pda.org http://www.pda.org/pdafda2012 Vol. 77, no. 152 Office of the Federal Register, National Archives and Records Administration 2012-08-07 continuing daily deposited born digital 347 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-08-07 P0b002ee18338fb81 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr07au12 https://www.govinfo.gov/app/details/FR-2012-08-07 https://www.govinfo.gov/content/pkg/FR-2012-08-07/pdf/FR-2012-08-07.pdf https://www.govinfo.gov/content/pkg/FR-2012-08-07/xml/FR-2012-08-07.xml fdlp 46929 47266 DGPO 2012-08-07 2024-06-03 FR-2012-08-07 machine generated eng FR FR-2012-08-07 77 152