[Federal Register Volume 67, Number 61 (Friday, March 29, 2002)]
[Notices]
[Pages 15210-15211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-7579]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Drug Manufacturing Inspections; Public Workshops

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshops.

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    The Food and Drug Administration (FDA) is announcing a series of 
workshops to discuss the application of a systems-based approach to 
drug manufacturing inspections. The workshops, which will be held in 
collaboration with the Consumer Healthcare Products Association (CHPA), 
are intended to provide a regulatory perspective on the systems-based 
approach to inspections.

[[Page 15211]]

    Date and Time: See table 1 following the ``Location'' section of 
this document.
    Location: See table 1 below

                                 Table 1
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    Meeting Address        Date and Local Time      FDA Contact Person
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NEW JERSEY: Sheraton     Monday, June 17, 2002,   Erik N. Henrikson
 Meadowlands Hotel, 2     from 8:30 a.m. to 4:30
 Meadowlands Plaza,       p.m.
 East Rutherford, NJ,
 201-896-0500.
PUERTO RICO: San Juan    Monday, July 15, 2002,   Do.
 Marriott Hotel, 1309     from 8:30 a.m. to 4:30
 Ashford Ave., San        p.m.
 Juan, PR, 800-981-
 8546.
CALIFORNIA: Manhattan    Monday, August 5, 2002,  Do.
 Beach Marriott Hotel,    from 8:30 a.m. to 4:30
 1400 Parkview Dr.,       p.m.
 Manhattan Beach, CA,
 310-546-7511.
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    Contact:
    For information regarding participation by FDA: Erik N. Henrikson, 
Center for Drug Evaluation and Research (HFD-320), Food and Drug 
Administration, 7520 Standish Pl., Rockville, MD 20855, 301-827-0072, 
FAX 301-594-2202.
    For information regarding the program or registration: Bill 
Bradley, Consumer Healthcare Products Association (CHPA), 1150 
Connecticut Ave. NW., Washington, DC 20036, 202-429-9260, FAX 202-223-
6835.
    Registration: Anyone interested in the workshops can obtain 
registration information from Bill Bradley, CHPA (address above), or a 
brochure with the program and registration form is available at http://www.chpa-info.org/meetings/pdfs/2002workshops_updated_22602.pdf. This 
material is also available from http://www.fda.gov.cder/calendar. Space 
is limited. Please preregister by the Friday prior to each of these 
meetings to confirm your participation. If you need special 
accommodations due to a disability, please contact Erik N. Henrikson 
(address above) at least 7 days in advance.

SUPPLEMENTARY INFORMATION:   
    Who Should Attend? This announcement is directed toward 
professionals involved in the manufacture, control, and regulation of 
prescription or over-the-counter drugs who will benefit from these 
workshops, including: Process/production engineers, quality assurance/
quality control and regulatory affairs professionals, auditors, 
repackers and relabelers, consultants, regulatory investigators and 
good manufacturing practice compliance officials, and reviewing 
chemists. Other entities or individuals may also be interested in 
attending.
    Is There a Registration Fee for This Workshop? Yes, a registration 
fee of $320.00 payable to CHPA is required for this workshop. This 
registration fee includes workshop reference materials and lunch on 
each day. Government employees qualify for a discounted rate of $75.00.
    How Can I Get Additional Information, Including Copies of This 
Document or Other Related Documents? The notice of participation form, 
information about the workshops, and other related documents are 
available from the information contacts (addresses above) or on the 
Internet at http://www.fda.gov.cder/calender.

    Dated: March 22, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-7579 Filed 3-28-02; 8:45 am]
BILLING CODE 4160-01-S