Document ID: FDA-2012-N-0001-0079
Agency: fda
Document Type: Notice
Title: FDA, Xavier University Global Outsourcing Conference
Posted Date: 2012-07-13T04:00Z

[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41416-41417]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17077]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Food and Drug Administration/Xavier University Global Outsourcing 
Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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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 
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:

                                         Table 1--Registration Fees \1\
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                                           Fee on or before         Fee August  6th-       Fee September  3rd-
               Attendee                       August 5th             September 2nd            September 23rd
----------------------------------------------------------------------------------------------------------------
Industry.............................                     $995                   $1,295                   $1,495
Small Business (<100 employees)......                      800                      900                    1,000
Consultants..........................                      500                      600                      700
Startup Manufacturers/Academic.......                      200                      250                      300
Media/Government.....................                     Free                     Free                     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, email, and payment information for 
the fee to Xavier University, Attention: Sue Bensman, 3800 Victory 
Pkwy., Cincinnati, OH 45207. An email will be sent confirming your 
registration.
    Attendees are responsible for their own accommodations. The 
conference headquarters hotel is the Downtown Cincinnati Hilton 
Netherlands Plaza, 35 West Fifth St., Cincinnati, OH 45202, 513-421-
9100. To make reservations online, please visit the ``Venue & 
Logistics'' link at http://www.XavierGOC.com to make reservations. 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:

 FDA International Initiatives
 European Union Regulator Perspective

[[Page 41417]]

 United States Pharmacopeia Chapter Development Impact
 Total Cost of Quality
 FDA New Inspectional Approach and Trends
 Supplier Selection and Due Diligence
 How to Operate in Different Regions of the World
 Establishing a Meaningful Supplier Qualification Program
 Supply Chain Development
 Finished Product Distribution Channel
 Enterprise Resource Planning
 Self Inspections & Corporate Audits
 Quality Agreements
 Business Process Management
 Global Standards Association Near Term Solutions
The conference includes:
 Deep Dive Lunch Sessions
 Live Polling Used by Speakers
 Case Studies
 Small Group Discussions
 Networking Lunch by Topic

    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 (Pub. L. 105-115), 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: July 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17077 Filed 7-12-12; 8:45 am]
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