Document ID: FDA-2012-N-0001-0064
Agency: fda
Document Type: Notice
Title: Redefining the C in CGMP:  Creating, Implementing, and Sustaining a Culture of Compliance Workshop
Posted Date: 2012-05-07T04:00Z

[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Notices]
[Pages 26768-26769]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10894]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Food and Drug Administration/International Society for 
Pharmaceutical Engineering Cosponsorship Educational Workshop: 
Redefining the `C' in CGMP: Creating, Implementing, and Sustaining a 
Culture of Compliance

AGENCY: Food and Drug Administration, HHS.

[[Page 26769]]

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) Center for Drug Evaluation 
and Research, in cosponsorship with the International Society for 
Pharmaceutical Engineering (ISPE), is planning a multiday, educational 
public workshop entitled ``Redefining the `C' in CGMP: Creating, 
Implementing, and Sustaining a Culture of Compliance.''

DATES:  Date and Time: The public workshop will be held on June 4, 
2012, 9 a.m. to 5 p.m. and June 5, 2012, 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Renaissance 
Baltimore Harborplace Hotel, 202 E. Pratt St., Baltimore, MD 21202, 1-
800-535-1201.
    Contact Persons: FDA Contact: Rhonda Hill, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4341, Silver Spring, MD 20993, 301-796-
3267, rhonda.hill@fda.hhs.gov.
    ISPE Contact: Julianne Rill, Continuing Education Program Manager, 
600 N. Westshore Blvd., Suite 900, Tampa, FL 33609; Web site: 
http:[sol][sol]www.ispe.org/2012-gmp-conference; email: jrill@ispe.org. 
(FDA has verified the Web site address in this announcement but we are 
not responsible for any subsequent changes to the Web site in this 
announcement after this document publishes in the Federal Register.)
    Accommodations: Attendees are responsible for their own 
accommodations. Please mention ISPE/FDA Conference to receive the hotel 
room rate of $195.00 plus applicable taxes (available until May 7, 
2012, or until the ISPE room block is filled).
    If you need special accommodations due to a disability, please 
contact ISPE (see Contact Persons) at least 7 days in advance of the 
meeting.
    Registration: The ISPE registration fees cover the cost of 
facilities, materials, and refreshments. Seats are limited; please 
submit your registration as soon as possible. Workshop space will be 
filled in order of receipt of registration. Those accepted for the 
workshop will receive confirmation. Registration will close after the 
workshop is filled.

                          Cost of Registration
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ISPE member...............................  $1,695
ISPE nonmember (includes membership)......  2,035
Federal Government........................  750
FDA Planning Committee members and invited  Fee waived.
 speakers.
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    Please visit ISPE's Web site to confirm the prevailing registration 
fees.
    To register, please submit a registration form with your name, 
affiliation, mailing address, telephone, fax number, and email, along 
with a check or money order payable to ``ISPE.'' To register via the 
Internet, go to http:[sol][sol]www.ispe.org/2012-gmp-conference. The 
registrar will accept payment by major credit card (Visa/MasterCard/
AMEX only). For more information on the meeting registration, or for 
questions on the workshop, contact ISPE (see Contact Persons).

SUPPLEMENTARY INFORMATION: The workshop helps fulfill the Department of 
Health and Human Services' and FDA's important mission to protect the 
public health. The workshop will provide those engaged in FDA-regulated 
drug manufacturing operations with information on a number of topics 
concerning FDA requirements and expectations related to current good 
manufacturing practice (CGMP). The joint public workshop offers the 
opportunity for participants to join FDA representatives and industry 
experts in face-to-face dialogues. Each year, FDA speakers provide 
updates on current efforts affecting the development of global 
regulatory strategies, while industry professionals from some of 
today's leading pharmaceutical companies present case studies on how 
they employ strategies to manufacture high quality drugs in their daily 
processes. Through a series of sessions and meetings, the conference 
will provide participants with the opportunity to hear directly from 
FDA experts and representatives of global regulatory authorities on 
best practices. Topics for discussion include the following: (1) The 
Business Case For Change; (2) Quality Risk Management--When, What, and 
How; (3) Sustaining Compliance Consistency Throughout Your Company and 
Supplier Network; (4) IT Strategies--Cloud Computing, RFID, and Beyond; 
(5) The Future of Drug Manufacturing. To help ensure the quality of FDA 
regulated products, the workshop helps to achieve objectives set forth 
in section 406 of the FDA 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 workshop also is consistent with the Small Business Regulatory 
Enforcement Fairness Act of 1996 (Pub. L. 104-121), as outreach 
activities by Government Agencies to small businesses.

    Dated: May 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-10894 Filed 5-4-12; 8:45 am]
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