[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.
----------------------------------------------------------------------------------------------------------------
                                               Deadline to Register      Registrar and
   Workshop Address     Date and Local Time          and Fee               Cosponsor         FDA Contact Person
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

    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