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 2012-07-13 article Notices D09002ee1c7fcbebd D09002ee1c7fcbf4a 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) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled "FDA/Xavier University Global Outsourcing Conference." This public conference for the pharmaceutical industry is in direct alignment with the "FDA Strategic Priorities 2011-2015," and includes presentations from key FDA officials, global regulators, and industry experts. This conference drives collaboration on the topic of global outsourcing compliance by bringing pharmaceutical/biotechnology companies and contract partners to the same event to address the issues that reside on both sides of the contract. Expert presentations address the "how to" aspects of improving outsourced product quality through topics such as FDA International Initiatives, FDA Inspection Trends, Supply Chain Development, Quality Agreements, Supplier Qualification, and many more. The experience level of our audience has fostered engaged dialogue that has led to innovative initiatives. Dates and Times: The public conference will be held on September 24, 2012, from 8:30 a.m. to 5 p.m.; September 25, 2012, from 8:30 a.m. to 5:30 p.m.; and September 26, 2012, from 8:30 a.m. to 12:45 p.m. Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745- 3073 or 513-745-3396. Contact Persons: For information regarding this notice: Steven Eastham, Food and Drug Administration, Cincinnati South Office, 36 East Seventh Street, Cincinnati, OH 45202, 513-246-4134, email: steven.eastham@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073, email: phillipsm4@xavier.edu. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, and dinners for the 2 \1/2\ days of the conference. Early registration ends August 5, 2012. Standard registration ends September 2, 2012. Late registration occurs September 3 to September 23, 2012. There will also be onsite registration. The cost of registration is as follows: 77 FR 41416 https://www.govinfo.gov/app/details/FR-2012-07-13/2012-17077 2012-17077 fr13jy12-97 4160-01-P Docket No. FDA-2012-N-0001 https://www.govinfo.gov/app/details/FR-2012-07-13/2012-17077 https://www.govinfo.gov/content/pkg/FR-2012-07-13/html/2012-17077.htm https://www.govinfo.gov/content/pkg/FR-2012-07-13/pdf/2012-17077.pdf 2 p. 41416 41417 77 FR 41416 Food and Drug Administration/Xavier University Global Outsourcing Conference; Federal Register Vol. 77, Issue NOTICE 2012-17077 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2012-N-0001 4160-01-P 2012-17077 Notice of public conference.

The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled "FDA/Xavier University Global Outsourcing Conference." This public conference for the pharmaceutical industry is in direct alignment with the "FDA Strategic Priorities 2011-2015," and includes presentations from key FDA officials, global regulators, and industry experts. This conference drives collaboration on the topic of global outsourcing compliance by bringing pharmaceutical/biotechnology companies and contract partners to the same event to address the issues that reside on both sides of the contract. Expert presentations address the "how to" aspects of improving outsourced product quality through topics such as FDA International Initiatives, FDA Inspection Trends, Supply Chain Development, Quality Agreements, Supplier Qualification, and many more. The experience level of our audience has fostered engaged dialogue that has led to innovative initiatives. Dates and Times: The public conference will be held on September 24, 2012, from 8:30 a.m. to 5 p.m.; September 25, 2012, from 8:30 a.m. to 5:30 p.m.; and September 26, 2012, from 8:30 a.m. to 12:45 p.m. Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745- 3073 or 513-745-3396. Contact Persons: For information regarding this notice: Steven Eastham, Food and Drug Administration, Cincinnati South Office, 36 East Seventh Street, Cincinnati, OH 45202, 513-246-4134, email: steven.eastham@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073, email: phillipsm4@xavier.edu. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, and dinners for the 2 \1/2\ days of the conference. Early registration ends August 5, 2012. Standard registration ends September 2, 2012. Late registration occurs September 3 to September 23, 2012. There will also be onsite registration. The cost of registration is as follows:

Meetings: FDA, Xavier University Global Outsourcing Conference , phillipsm4@xavier.edu steven.eastham@fda.hhs.gov http://www.XavierGOC.com Vol. 77, no. 135 Office of the Federal Register, National Archives and Records Administration 2012-07-13 continuing daily deposited born digital 429 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-07-13 P0b002ee182ae3ebd 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13jy12 https://www.govinfo.gov/app/details/FR-2012-07-13 https://www.govinfo.gov/content/pkg/FR-2012-07-13/pdf/FR-2012-07-13.pdf https://www.govinfo.gov/content/pkg/FR-2012-07-13/xml/FR-2012-07-13.xml fdlp 41243 41661 DGPO 2012-07-13 2024-06-03 FR-2012-07-13 machine generated eng FR FR-2012-07-13 77 135