[Federal Register: March 29, 2002 (Volume 67, Number 61)]
[Notices]
[Page 15210-15211]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr02-80]
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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