[Federal Register: September 20, 2007 (Volume 72, Number 182)]
[Notices]
[Page 53778-53779]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se07-52]
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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 quality pharmaceutical production under
current good manufacturing practice (CGMP). The workshops, which will
be held in collaboration with the Parenteral Drug Association (PDA),
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 (HF-
18), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-9190, erik.henrikson@fda.hhs.gov, or
[[Page 53779]]
Wanda Neal, Parenteral Drug Association, 4350 East West Hwy., suite
200, Bethesda, MD 20814, 301-656-5900, FAX: 301-986-0296, neal@pda.org.
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?
We have scheduled four workshops. The locations and times are
listed in table 1 of this document.
Table 1.--Workshop Locations and Schedules
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Workshop Address Dates and Local Times
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Hyatt Regency Bethesda, 1 Bethesda Metro Center, Bethesda, November 1 and 2, 2007, from 9 a.m. to 5 p.m. each
MD 20814 day
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The Gresham Hotels, 23 Upper O'Connell St., Dublin 1, December 10 and 11, 2007, from 9 a.m. to 5 p.m.
Ireland each day
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Peking University, Beijing, China 100871 April 21 and 22, 2008, from 9 a.m. to 5 p.m. each
day
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Grand Hyatt Shanghai, Jin Mao Tower, 88 Century Blvd., April 24 and 25, 2008, from 9 a.m. to 5 p.m. each
Pudong, Shanghai, China 200121 day
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C. How Can I Participate?
You can participate in person. Anyone interested in the GMP
workshops can register through the contact person (see FOR FURTHER
INFORMATION CONTACT).
D. Is There a Registration Fee for This Workshop?
Yes, a registration fee is required for this workshop. The
registration fee includes workshop reference materials and meals.
Registration fees for the Bethesda, MD and Dublin, Ireland workshops
are listed in table 2 of this document. The registration fee for both
China locations (Beijing and Shanghai) is $550 with no discounts. All
fees are given in U.S. dollars.
Table 2.--Registration Fees for the Bethesda, MD and Dublin, Ireland Workshops
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Government Employee or
Date of Registration PDA Member Nonmember Health Authority Academic Student
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Through October 1, 2007 $1,295 $1,695 $350 $350\1\ $150
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After October 1, 2007 $1,495 $1,895 $405 $405\1\ $180
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\1\ Must be PDA member to receive this rate.
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 (see
FOR FURTHER INFORMATION CONTACT) and on the Internet at http://www.fda.gov/cder/workshop.htm
.
II. Background Information
A. Why Is FDA Cosponsoring These Workshops?
FDA is cosponsoring these 2-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: September 14, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-18556 Filed 9-19-07; 8:45 am]
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