2011-23482. Food and Drug Administration/Xavier University Global Outsourcing Conference

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public conference.

SUMMARY:

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 2.5-day 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 Strategic Procurement, End-to-End lifecycle product management, Managing Global Complex Supply Chains, and other topics. The experience level of our audience has fostered engaged dialog that has lead to innovative initiatives.

Dates and Times: The public conference will be held on October 3, 2011, from 8:30 a.m. to 5 p.m., October 4, 2011, from 8:30 a.m. to 5 p.m., and October 5, 2011, from 8:30 a.m. to 1 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 document: Steven Eastham, Food and Drug Administration, Cincinnati South Office, 36 East Seventh Street, Cincinnati, OH 45202, 513-246-4134, e-mail: [e-mail].

For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073, e-mail: [e-mail].

Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, dinners, and dinner speakers for the 2.5 days of the conference. Prior online registration or registration by mail must be done by October 3, 2011. There will also be onsite registration. The cost of registration is as follows:

Table 1—Registration Fees ¹

Attendee	Fee
Industry	$1,495
Small Business (<100 employees)	1,000
Consultants	700
Startup Manufacturer	300
Academic/Government	300
Media	Free
1 The fourth registration from the same company is free.

The following forms of payment will be accepted: American Express, Visa, Mastercard, and company checks.

To register online for the public conference, please visit the “Register Now” link on the conference Web site at http://www.XavierGOC.com. FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.

To register by mail, please send your name, title, firm name, address, telephone and fax numbers, e-mail, and payment information for the fee to Xavier University, Attention: Sue Bensman, 3800 Victory Pkwy., Cincinnati, OH 45207. An e-mail will be sent confirming your registration.

Attendees are responsible for their own accommodations. The conference headquarter hotel is the Downtown Cincinnati Hilton Netherlands Plaza, 35 West Fifth Street, Cincinnati, OH 45202, 513-421-9100. To make reservations online, please visit the “Venue & Logistics” link at http://www.XavierGOC.com. The hotel is expected to sell-out during this timeframe; so, early reservation in the conference room-block is encouraged.

If you need special accommodations due to a disability, please contact Marla Phillips (see Contact Persons) at least 7 days in advance of the conference.

SUPPLEMENTARY INFORMATION:

The public conference helps fulfill the Department of Health and Human Services and FDA's important mission to protect the public health. The conference will provide those engaged in FDA-regulated outsourcing with information on the following topics:

• Regulatory Expectations for Outsourcing Roles and Responsibilities, Supply Chain Quality, and Challenges Observed,
• Price Versus Total Cost of Ownership,
• Strategic Procurement,
• Development and Commercial Contracts,
• Functional Quality Agreements,
• Meaningful Metrics,
• FDA and the Medicines and Healthcare Products Regulatory Agency Inspection Trends and Enforcement,
• McNeil Case Study and Living Under Consent Decree,
• Practical Risk Management and Case Studies of Litigation,
• Supplier Qualification Program,
• Third Party Initiatives and Impact,
• Operationalizing Quality-by-Design,
• Audit Panel to Cover Focus Areas for Due Diligence Audits, Ongoing Audit/Oversight, and Supply Chain Audits,
• The Power of Integrated Supply Chains—By Design. Drive to the Source of the Frustrations,
• End-to-End Planning for Successful Launch,
• Pharma Case Study on How to Manage a Global Complex Supply Chain,
• USP <1079>: Good Storage and Distribution Practices, and USP <1083> Pedigree and Track and Trace Presented By the Author, and
• Next Steps for the Industry.

FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices. The conference helps to achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The conference also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121) by providing outreach activities by Government Agencies to small businesses.

Dated: September 8, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.