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| GHTF > Meetings and Training > Conferences >8th GHTF Conference - Ottawa, Canada 18-22 September 2000 > ISO/FDIS 9001:2000 Information Update Information Session Brief |
This brief is also available in Word and PDF format.
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Title:
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ISO/FDIS 9001:2000 Information Update |
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Time:
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Friday, 22 September 8:30 AM - 1:00 PM |
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Convenor:
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Kimberly A. Trautman GMP/ Quality Systems Expert Division of Enforcement III (CDRH) U.S Food and Drug Administration KAT@cdrh.fda.gov (301) 594-4648 |
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Topic:
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This session is to provide the most up-to-date information on ISO/FDIS 9001:2000 and ISO/FDIS 9000:2000 as a result of the ISO TC 176 meeting in Kyoto, Japan in July. The session will discuss the key areas of the new 9000 series and how the requirements will effect ISO 13485 and ISO 13488. Further discussion will occur on how this effects the overall medical device sector. |
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Speakers:
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Kimberly A. Trautman, Chair SG#3 GHTF Edward Kimmelman, Chair WG#1 ISO TC 210 Pierre Landry, Chair SC#1 ISO TC 176 |
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Attachments:
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If available at the time, copies of ISO/FDIS 9000:2000 and ISO/FDIS 9001:2000. |
Updated 22 July 2004
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