[Federal Register Volume 62, Number 167 (Thursday, August 28, 1997)]
[Notices]
[Page 45670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22978]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
System Suitability (Validation) of Chromatographic Analysis/Out-
of-Specification Results; Notice of Public Meetings
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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The Food and Drug Administration (FDA) is announcing that it will
hold a series of two public meetings that will be offered in two
locations. The topics to be discussed are validating chromatographic
systems and evaluating out-of-specification test results.
Date and Time: The public meetings will be held on September 12,
1997, 8 a.m. to 12 m. and 1 p.m. to 4 p.m.; and September 24, 1997, 2
p.m. to 5:30 p.m. (both meetings).
Location: On September 12, 1997, the meetings will be held at the
Independence Seaport Museum Penn's Landing, 211 South Columbus Blvd.,
and Walnut St., Philadelphia, PA, 215-413-8622, FAX 215-925-6713. On
September 24, 1997, the meetings will be held at the Hyatt Regency
Bethesda, One Bethesda Metro Center, Bethesda, MD, 301-657-1234, FAX
301-657-6453.
Contact: Richard A. Baldwin, Division of Field Science (HFC-141),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-443-6388, FAX 301-443-5153.
Registration: Registration for the September 24, 1997, meetings is
required through the Parenteral Drug Association. For more information
on how to register, contact the Parenteral Drug Association at 301-986-
0293, or e-mail info@pda.org.
SUPPLEMENTARY INFORMATION: On September 12, 1997, FDA's Office of
Regulatory Affairs and the Office of External Affairs are cosponsoring
two meetings entitled ``System Suitability (Validation) for
Chromatographic Analysis'' and ``Out-of Specification Results.'' On
September 24, 1997, FDA, in cooperation with the Parenteral Drug
Association, will offer the same meetings in Bethesda MD. The goal of
these meetings is to provide consistent practices and procedures
between FDA and the pharmaceutical industry.
Requests for handouts are available from the Division of Field
Science. Submit requests to Denise Jones, Division of Field Science
(HFC-141), Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20857.
If you need special accommodations due to a disability, please
notify the contact person at least 7 days in advance.
Dated: August 22, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-22978 Filed 8-25-97; 4:44 pm]
BILLING CODE 4160-01-F
