[Federal Register Volume 64, Number 175 (Friday, September 10, 1999)]
[Notices]
[Pages 49192-49196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23633]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration/Industry Exchange Workshop on
Medical Device Quality Systems Inspection Technique; Public Workshops
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of workshops.
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SUMMARY: The Food and Drug Administration (FDA), Office of the
Commissioner, Office of Regulatory Affairs, Center for Devices and
Radiological Health, and the Regional Small Business Assistance Offices
in cooperation with the American Society for Quality, Association of
Food and Drug Officials, BioFlorida, Inc., Health Industry
Manufacturers Association, Medical Alley, New England Biomedical
Discussion Group, Organization of Regulatory and Clinical Associates,
Pharmaceutical Quality Institute, and the Regulatory Affairs
Professionals Society is announcing a series of workshops on the FDA
Quality System Inspection Technique (QSIT). Topics for discussion
include: Development of QSIT, Compliance Program and Warning Letter
(Pilot), Management Controls, Corrective and Preventative Action,
Design Controls, Production and Process Controls, and Industry
Perspective of QSIT. Through the workshops, FDA seeks to increase the
medical device community's understanding of QSIT, and ensure that the
device industry takes appropriate actions to establish effective
quality systems, thus preventing regulatory problems when inspections
occur.
Date and Time: See Table 1 in the SUPPLEMENTARY INFORMATION section
of this document.
Location: See Table 1 in the SUPPLEMENTARY INFORMATION section of
this document.
Registration: Send registration information as listed in the
SUPPLEMENTARY INFORMATION section of this document, along with the
correct payment amount, to the registrar for the site you wish to
attend. Fees cover refreshments, organization and site costs, and
materials. Space is limited, therefore interested parties are
encouraged to register early. If you need special accommodations due to
a disability, please inform the registrar for your site at least 7 days
in advance of the workshop.
Contact: Herman B. Janiger, Northeast Regional Office (HFRNE-17),
Food and Drug Administration, 850 Third Ave., Brooklyn, NY 11232, 718-
340-7000, ext. 5528.
SUPPLEMENTARY INFORMATION: In the fall of 1999, FDA field offices will
begin using the QSIT nationwide as the primary tool for medical device
good manufacturing practice/quality system inspections. QSIT was
developed using a collaborative effort with stakeholders and tested in
three districts. The following workshops are scheduled to increase the
medical community's understanding of QSIT:
[[Page 49193]]
Table 1.
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Deadline to Register Registrar and
Workshop Address Date and Local Time and Fee Cosponsor FDA Contact Person
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EAST ELMHURST: Crowne Tuesday, October 12, Tuesday, September James Blanchard, Herman B. Janiger,
Plaza, LaGuardia 1999, 8:30 a.m. to 28, 1999, $170. Health Industry Small Business
Airport, 104-04 4:30 p.m. Manufacturers Representative,
Ditmars Blvd., East Association, 1200 G Northeast Regional
Elmhurst, NY 11369, St. NW, suite 400, Office, 718-340-
718-457-6300. Washington, DC 7000, ext. 5528.
20005, 202-434-7231,
FAX 202-783-8750.
PRINCETON: Holiday Thursday, October 14, Thursday, September Satish Laroia, Marie T. Falcone,
Inn, US Route 1 & 1999, 8:30 a.m. to 30, 1999, $145. Pharmaceutical Small Business
Ridge Rd., 4:30 p.m. Quality Institute, Representative,
Princeton, NJ 08540, 33 Aspen Circle, Central Regional
609-452-2400 or 800- Edison, NJ 08820, Office, 215-597-
465-4329. 973-890-1440, FAX 2120, ext. 4003.
732-549-7487.
MINNEAPOLIS: Holiday Thursday, October 21, Friday, October 15, Lisa Miller, Medical Marie T. Falcone,
Inn, Minneapolis 1999, 8:30 a.m. to 1999, $160 (member), Alley, 1550 Utica Small Business
West, 9970 Wayzata 4:30 p.m. $235 (nonmember). Ave. South St., Representative,
Blvd., Minneapolis, Louis Park, MN 612- Central Regional
MN 55426, 612-593- 542-3077, FAX 612- Office, 215-597-
1918 or 800-465- 542-3088, or 2120, ext. 4003.
4329. ``www.medicalalley.o
rg''.
ORLANDO: Radisson Thursday, October 28, Thursday, October 14, Larry M. Clark, Barbara Ward-Groves,
Orlando Airport, 1999, 8:30 a.m. to 1999, $90. BioFlorida, Inc., Small Business
5555 Hazeltine 4:30 p.m. 15205 SW 78th CT, Representative,
National Dr., Miami, FL 33157, 305- Southeast Regional
Orlando, FL 32812, 971-1495, FAX 305- Office, 404-253-
407-856-0100 or 800- 971-1496. 2238.
333-3333.
CAMBRIDGE: Volpe Tuesday, November 2, Tuesday, October 19, Terrence Sullivan, Herman B. Janiger,
National 1999, 8:30 a.m. to 1999, $50. New England Small Business
Transportation 4:30 p.m. Biomedical Representative,
Systems, Center Discussion Group, Northeast Regional
Auditorium, rm. 1- P.O. Box 1282, Office, 718-340-
11, Bldg. 2, Kendall Attleboro Falls, MA 7000, ext. 5528.
Sq., Cambridge, MA 02763-0282, 508-643-
02142-1093. 0434, FAX 508-643-
2237.
HOUSTON: Marriott Thursday, November 4, Thursday, October 21, Denise Rooney, Brenda C. Baumert,
West Loop, 1750 West 1999, 8:30 a.m. to 1999, $170. Association of Food Small Business
Loop South, Houston, 4:30 p.m. and Drug Officials, Representative,
TX 77027, 713-960- P.O. Box 3425, York, Southwest Regional
0111 or 800-228- PA 17402, 717-757- Office, 214-655-
9290. 2888, FAX 717-755- 8100, ext. 133.
8089.
OAK BROOK: Marriott Wednesday, November Wednesday, October Susan B. Jacobs, Marie T. Falcone,
Oak Brook, 1401 West 10, 1999, 8:30 a.m. 27, 1999, $80. American Society for Small Business
22d St., Oak Brook, to 4:30 p.m. Quality, 3516 North Representative,
IL 60523, 630-573- Wilshire Dr., Central Regional
8555 or 800-228- Palatine, IL 60067, Office, 215-597-
9290. 847-359-4456, FAX 2120, ext. 4003.
847-359-4512.
ATLANTA: Sheraton Tuesday, November 16, Tuesday, November 2, Denise Rooney, Barbara Ward-Groves,
Colony Sq., 188 14th 1999, 8:30 a.m. to 1999, $170. Association of Food Small Business
St. NE., Atlanta, GA 4:30 p.m. and Drug Officials, Representative,
30361, 404-892-6000. P.O. Box 3425, York, Southeast Regional
PA 17402, 717-757- Office, 404-253-
2888, FAX 717-755- 2238.
8089.
FOSTER CITY: Crowne Thursday, November Thursday, November 4, Courtney Ford, Acting Small
Plaza Hotel, 1221 18, 1999, 8:30 a.m. 1999, $120. Regulatory Affairs Business
Chess Dr., Foster to 4:30 p.m. Professionals Representative,
City, CA 94404, 650- Society, 12300 Pacific Regional
570-5700. Twinbrook Pkwy., Office, 510-637-
suite 350, 3980.
Rockville, MD 20852-
1606, 301-770-2920,
FAX 301-770-2924.
BELLEVUE: Rockwell Tuesday, November 23, Sunday, November 7, Jaimee Hansen, Acting Small
Institute, 13218 1999, 8:30 a.m. to 1999, $100. Organization of Business
North East 20th St., 4:30 p.m. Regulatory & Representative,
Bellevue, WA 90005, Clinical Associates, Pacific Regional
425-747-7272. P.O. Box 3490, Office, 510-637-
Redmond, WA 98073- 3980.
3490, 425-487-7179,
FAX 425-487-8666.
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The workshops, scheduled above, will help to implement the FDA Plan
for Statutory Compliance (developed under section 406 of the FDA
Modernization Act (21 U.S.C. 393)) through working more closely with
stakeholders and
[[Page 49194]]
ensuring access to needed scientific and technical expertise. These
workshops also comply with the Small Business Regulatory Enforcement
Fairness Act (Public Law 104-121) that requires outreach activities by
Government agencies directed to small businesses.
This notice announcing the workshops and a registration form may
also be accessed at the CDRH website at ``http://www.fda.gov/cdrh/
fedregin.html''.
The following information is requested for registration:
[[Page 49195]]
Registration Form
Quality System Inspection Technique (QSIT)
Regional Medical Device Workshop
Instructions: To register, complete this form and mail with registration
fee to the Registrar for the workshop you wish to attend.
Date,___________________________________________________________________
_____________
Location,_______________________________________________________________
_____________
Fee
enclosed,______________________________________________________________
_________
Name,___________________________________________________________________
_____________
Title,__________________________________________________________________
_____________
Company,________________________________________________________________
___________
Address,________________________________________________________________
___________
Telephone,______________________________________________________________
___________
Fax,____________________________________________________________________
_____________
E-
mail___________________________________________________________________
_________
[[Page 49196]]
Dated: September 2, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-23633 Filed 9-7-99; 4:16 pm]
BILLING CODE 4160-01-F