[Federal Register: August 31, 2005 (Volume 70, Number 168)]
[Notices]
[Page 51825-51826]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31au05-133]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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, henriksone@cder.fda.gov or Qiang
Zheng, Peking University, Beijing, China, 86-10-6275-6489, FAX: 86-10-
6275-1207, zhengqiang@pku.edu.cn.
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
------------------------------------------------------------------------
Workshop Address Dates and Local Times
------------------------------------------------------------------------
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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