[Federal Register Volume 70, Number 168 (Wednesday, August 31, 2005)]
[Notices]
[Pages 51825-51826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17248]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Educational Workshops on Current Good Manufacturing Practices; 
Public Workshops

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshops.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a series 
of educational workshops on current good manufacturing practice (CGMP). 
The workshops, which will be held in collaboration with Peking 
University (Beijing, China) and the International Society for 
Pharmaceutical Engineering (ISPE), are intended to educate participants 
on current methods for compliance with good manufacturing practices 
(GMP). The workshops are being offered to help ensure effective CGMP 
programs and to further the common goals of FDA and providers of 
quality pharmaceutical products.

DATES: See table 1 in the SUPPLEMENTARY INFORMATION section of this 
document.

ADDRESSES: See table 1 in the SUPPLEMENTARY INFORMATION section of this 
document.

FOR FURTHER INFORMATION CONTACT: Erik N. Henrikson, Center for Drug 
Evaluation and Research (HFD-320), Food and Drug Administration, 11919 
Rockville Pike, Rockville, MD 20852,

[[Page 51826]]

301-827-9035, FAX: 301-827-8907, <a href="/cdn-cgi/l/email-protection#375f5259455e5c4458595277545352451951535619505841"><span class="__cf_email__" data-cfemail="9ff7faf1edf6f4ecf0f1fadffcfbfaedb1f9fbfeb1f8f0e9">[email protected]</span></a> or Qiang 
Zheng, Peking University, Beijing, China, 86-10-6275-6489, FAX: 86-10-
6275-1207, <a href="/cdn-cgi/l/email-protection#c4beaca1aaa3b5ada5aaa384b4afb1eaa1a0b1eaa7aa"><span class="__cf_email__" data-cfemail="ccb6a4a9a2abbda5ada2ab8cbca7b9e2a9a8b9e2afa2">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Who Should Attend?

    This announcement is directed towards professionals involved in the 
manufacture, control, and regulation of pharmaceutical products who 
will benefit from these workshops, including process/production 
engineers, manufacturing personnel, quality assurance/quality control 
and regulatory affairs professionals, consultants, regulatory 
investigators and CGMP compliance officials. Other entities or 
individuals may also be interested in attending.

B. Where and When Will These Workshops Be Held?

    The location and times for the two workshops are listed in table 1 
of this document.

                Table 1.--Workshop Location and Schedules
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          Workshop Address                  Dates and Local Times
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Ying Jie Convention Center, Peking   December 5 through 7, 2005, from 9
 University, Beijing, China           a.m. to 5 p.m. each day.
Ying Jie Convention Center, Peking   April 24 through 26, 2006, from 9
 University, Beijing, China           a.m. to 5 p.m. each day.
------------------------------------------------------------------------

C. How Can I Participate?

    You can participate in person. Anyone interested in the GMP 
workshops can register through the contact person in the FOR FURTHER 
INFORMATION CONTACT section of this document.

D. Is There a Registration Fee for These Workshops?

    Yes, a registration fee of $440 is required for this workshop. This 
registration fee includes workshop reference materials and meals. 
Government employees qualify for a discounted rate of $120.

E. How Can I Get Additional Information?

    The notice of participation form, information about the workshops, 
and other related documents are available from the contact person in 
the FOR FURTHER INFORMATION CONTACT section of this document or from 
the Internet at http://www.fda.gov/cder/meeting/CTP2005.htm.

II. Background Information

A. Why Is FDA Cosponsoring These Workshops?

    FDA is cosponsoring these 3-day workshops to provide information 
and training opportunities for industry as well as CGMP compliance 
officials.

B. What Will Be Covered?

    The workshops will provide information on specific topics designed 
to educate and guide participants on methodologies and implementation 
of CGMP as applied to quality drug manufacturing. Presentations by both 
FDA and industry will provide a regulatory and practical perspective on 
the current relevant critical topics.

    Dated: August 24, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-17248 Filed 8-30-05; 8:45 am]
BILLING CODE 4160-01-S


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