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Regulatory Information
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2010-09-22
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Regulatory Site Visit Training Program
Notices
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D09002ee1bdddea49
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is reannouncing the invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. The purpose of this notice is to invite biologics facilities to contact CBER for more information if they are interested in participating in this program.
72 FR 4713
https://www.govinfo.gov/app/details/FR-2007-02-01/E7-1576
E7-1576
fr01fe07-56
4160-01-S
Docket No. 2004N-0408
https://www.govinfo.gov/app/details/FR-2007-02-01/E7-1576
https://www.govinfo.gov/content/pkg/FR-2007-02-01/html/E7-1576.htm
https://www.govinfo.gov/content/pkg/FR-2007-02-01/pdf/E7-1576.pdf
2 p.
4713
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72 FR 4713
Regulatory Site Visit Training Program; Federal Register Vol. 72, Issue
NOTICE
E7-1576
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2007-03-05
Docket No. 2004N-0408
4160-01-S
E7-1576
Notice.
The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is reannouncing the invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. The purpose of this notice is to invite biologics facilities to contact CBER for more information if they are interested in participating in this program.
Submit written or electronic requests for participation in this program by March 5, 2007. The request should include a description of your facility relative to products regulated by CBER. Please specify the physical address of the site you are offering.
Lonnie Warren-Myers, Division of Manufacturers Assistance and Training, Center for Biologics Evaluation and Research (HFM-49), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-2000, FAX: 301-827- 3079, e-mail: matt@cber.fda.gov.
Center for Biologics Evaluation and Research:
Regulatory Site Visit Training Program,
matt@cber.fda.gov
http://www.fda.gov/dockets/ecomments
Federal Register
Vol. 72, no. 21
Office of the Federal Register, National Archives and Records Administration
2007-02-01
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337 p.
Table of Contents:
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GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2007-02-01
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0042-1219
0364-1406
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000582072
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https://www.govinfo.gov/app/details/FR-2007-02-01
https://www.govinfo.gov/content/pkg/FR-2007-02-01/pdf/FR-2007-02-01.pdf
https://www.govinfo.gov/content/pkg/FR-2007-02-01/xml/FR-2007-02-01.xml
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2010-09-22
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FR-2007-02-01
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FR-2007-02-01
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