FDA Qsr 820要1点简介
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Transcript of FDA Qsr 820要1点简介
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21 CFR 820 Kim Trautman
: Barbara Richards
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FDA 21 820 21 CFR 820
1997 6 1 1978 GMP
GMP 1978 1997 1997
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21 CFR 820 Kim Trautman
: Barbara Richards
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21 CFR 820
IVD
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21 CFR 820 Kim Trautman
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25 50 500 1000
90 establish 3Ddefinedocumentdo
3D
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21 CFR 820 Kim Trautman
: Barbara Richards
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21 CFR 820 Kim Trautman
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7 7 C7
FDA
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21 CFR 820 Kim Trautman
: Barbara Richards
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FDA
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21 CFR 820 Kim Trautman
: Barbara Richards
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CEO COO
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21 CFR 820 Kim Trautman
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3 3
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21 CFR 820 Kim Trautman
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35
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21 CFR 820 Kim Trautman
: Barbara Richards
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6000
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21 CFR 820 Kim Trautman
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[
device master records
1978 GMP GMP 1980 MDR FDA
35% 47%
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21 CFR 820 Kim Trautman
: Barbara Richards
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CD 90%
1990 FDA
1990
FDA
50
60
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21 CFR 820 Kim Trautman
: Barbara Richards
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FDA FDA
FDA
FDA IDE IDE
GMP IDE GMP 820.30.
[]
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21 CFR 820 Kim Trautman
: Barbara Richards
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[]
820.30.
FDA []
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21 CFR 820 Kim Trautman
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8 8
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8
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21 CFR 820 Kim Trautman
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21 CFR 820 Kim Trautman
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DMR
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21 CFR 820 Kim Trautman
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21 CFR 820 Kim Trautman
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FDA
FDA
FDA
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21 CFR 820 Kim Trautman
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10 10 10
8
8 8
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10 15
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FDA
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21 CFR 820 Kim Trautman
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820.30.
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820.50.
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2008 2009
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12
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176 ISO 9001
21 CFR 820.50.
820.70
820.70B
820.70B 820.30
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820.30I
820.30I
820.75
820.40
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100 1000
820.70 I
CAPA FDA
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820.70I Excel
Excel FDA
820.75
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820.75
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5 5 5
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FDA
6
FDA
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820.75 820.75
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820.100 CAPA
820.100
2008
CAPA
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FDA 43s
820.100
CAPA
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ISO 9000
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820.100
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5 500
100% 20% 80%
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CAPA
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21 CFR 820 Kim Trautman
: Barbara Richards
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CAPA
FDA 820.198
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CAPA
FDA
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: Barbara Richards
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: Barbara Richards
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FDA FDA ISO
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: Barbara Richards
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FDA
CAPA
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FDA
FDA
FDA FDA
FDA
QSITQSIT
FDA
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FDA FDA QSIT
FDA
QSIT
820 PMA HDE
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FDA
FDA
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