[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 [email protected].
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