[Federal Register Volume 78, Number 87 (Monday, May 6, 2013)]
[Notices]
[Pages 26375-26376]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10651]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Food and Drug Administration/International Society for 
Pharmaceutical Engineering Co-Sponsorship Educational Workshop: 
Redefining the `C' in CGMP (Current Good Manufacturing Practices): 
Creating, Implementing, and Sustaining a Culture of Quality

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

-----------------------------------------------------------------------

    The Food and Drug Administration (FDA), in co-sponsorship with the 
International Society of Pharmaceutical Engineering (ISPE), is 
announcing a conference entitled ``Redefining the `C' in CGMP: 
Creating, Implementing and Sustaining a Culture of Quality'' 
Pharmaceutical Quality System (ICH Q10) Conference.
    The conference will span 3 days and is dedicated to teaching the 
principles of CGMP, reaping the benefits that come from establishing 
and maintaining a state of control, implementing continual improvement, 
enhancing regulatory compliance, and meeting quality objectives every 
day. The conference will take place in Baltimore, MD, and will draw on 
the best industry and regulator contributors on this topic.
    Date and Time: The conference will be held on June 11, 2013, from 
8:30 a.m. to 5 p.m.; June 12, 2013, from 8 a.m. to 5 p.m.; and June 13, 
2013, from 8 a.m. to 4:30 p.m.
    Location: The event will be held at the Renaissance Baltimore 
Harborplace Hotel, 202 East Pratt St., Baltimore, MD 21201, 1-800-535-
1201.
    Contact Person: Nancy Berg, President, International Society for 
Pharmaceutical Engineering, 600 North Westshore Blvd., suite 900, 
Tampa, FL 33609, Web site: http://www.ISPE.org/CGMP.
    Conference attendees are responsible for their own accommodations.
    Registration: You are encouraged to register at your earliest 
convenience. The ISPE registration fees cover the cost of facilities, 
materials, and breaks. Seats are limited; please submit your 
registration as soon as possible. Conference space will be filled in 
order of receipt of registration. Those accepted to the conference will 
receive confirmation. Registration will close after available 
conference space is filled. Onsite registration will be available on a 
space available basis on the day of the

[[Page 26376]]

public conference beginning at 7 a.m. on June 11, 2013. The cost of 
registration is as follows:

------------------------------------------------------------------------
 
------------------------------------------------------------------------
ISPE Member............................  $1,545 (prior to May 13);
                                          $1,745 (after May 13 and
                                          onsite).
ISPE Nonmember.........................  $1,905 (prior to May 13);
                                          $2,115 (after May 13 and
                                          onsite).
ISPE New Member........................  $1,814 (prior to May 13);
                                          $2,014 (after May 13 and
                                          onsite).
Federal Government Employee registering  $500.
 prior to/after May13.
FDA Planning Committee Members and       (free) Fee Waived.
 Invited Speakers.
ISPE Active, Functional and Program      $1,005 (prior and after May
 Committee Members.                       13).
Student (prior to/after May 13)........  $200.
Individuals from Academia/Emerging       $1,005 (prior to May 13);
 Economy.                                 $1,135 (after May 13 and
                                          onsite).
------------------------------------------------------------------------

    Registration instructions: To register, please submit your name, 
affiliation, mailing address, phone number, fax number, and email 
address, along with a check or money order payable to ``ISPE.'' To 
register via the Internet, go to the ISPE Web site, www.ISPE.org, to 
confirm the prevailing registration fees.

    Dated: May 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-10651 Filed 5-3-13; 8:45 am]
BILLING CODE 4160-01-P