[Federal Register Volume 72, Number 182 (Thursday, September 20, 2007)]
[Notices]
[Pages 53778-53779]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-18556]


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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, [email protected], or

[[Page 53779]]

    Wanda Neal, Parenteral Drug Association, 4350 East West Hwy., suite 
200, Bethesda, MD 20814, 301-656-5900, FAX: 301-986-0296, [email protected].

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]
BILLING CODE 4160-01-S