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21 CFR 820 Kim Trautman
: Barbara Richards
1
FDA 21 820 21 CFR 820
1997 6 1 1978 GMP
GMP 1978 1997 1997
21 CFR 820 Kim Trautman
: Barbara Richards
2
21 CFR 820
IVD
21 CFR 820 Kim Trautman
: Barbara Richards
3
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21 CFR 820 Kim Trautman
: Barbara Richards
4
21 CFR 820 Kim Trautman
: Barbara Richards
5
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21 CFR 820 Kim Trautman
: Barbara Richards
6
FDA
21 CFR 820 Kim Trautman
: Barbara Richards
7
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21 CFR 820 Kim Trautman
: Barbara Richards
8
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21 CFR 820 Kim Trautman
: Barbara Richards
9
35
21 CFR 820 Kim Trautman
: Barbara Richards
10
6000
21 CFR 820 Kim Trautman
: Barbara Richards
11
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1978 GMP GMP 1980 MDR FDA
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21 CFR 820 Kim Trautman
: Barbara Richards
12
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FDA
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21 CFR 820 Kim Trautman
: Barbara Richards
13
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21 CFR 820 Kim Trautman
: Barbara Richards
14
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21 CFR 820 Kim Trautman
: Barbara Richards
15
21 CFR 820 Kim Trautman
: Barbara Richards
16
21 CFR 820 Kim Trautman
: Barbara Richards
17
8 8
21 CFR 820 Kim Trautman
: Barbara Richards
18
8
21 CFR 820 Kim Trautman
: Barbara Richards
19
21 CFR 820 Kim Trautman
: Barbara Richards
20
DMR
21 CFR 820 Kim Trautman
: Barbara Richards
21
21 CFR 820 Kim Trautman
: Barbara Richards
22
FDA
FDA
FDA
21 CFR 820 Kim Trautman
: Barbara Richards
23
21 CFR 820 Kim Trautman
: Barbara Richards
24
21 CFR 820 Kim Trautman
: Barbara Richards
25
10 10 10
8
8 8
21 CFR 820 Kim Trautman
: Barbara Richards
26
10 15
21 CFR 820 Kim Trautman
: Barbara Richards
27
21 CFR 820 Kim Trautman
: Barbara Richards
28
21 CFR 820 Kim Trautman
: Barbara Richards
29
FDA
21 CFR 820 Kim Trautman
: Barbara Richards
30
21 CFR 820 Kim Trautman
: Barbara Richards
31
21 CFR 820 Kim Trautman
: Barbara Richards
32
21 CFR 820 Kim Trautman
: Barbara Richards
33
21 CFR 820 Kim Trautman
: Barbara Richards
34
21 CFR 820 Kim Trautman
: Barbara Richards
35
820.30.
21 CFR 820 Kim Trautman
: Barbara Richards
36
820.50.
21 CFR 820 Kim Trautman
: Barbara Richards
37
2008 2009
21 CFR 820 Kim Trautman
: Barbara Richards
38
12
21 CFR 820 Kim Trautman
: Barbara Richards
39
176 ISO 9001
21 CFR 820.50.
820.70
820.70B
820.70B 820.30
21 CFR 820 Kim Trautman
: Barbara Richards
40
820.30I
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21 CFR 820 Kim Trautman
: Barbara Richards
41
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CAPA FDA
21 CFR 820 Kim Trautman
: Barbara Richards
42
820.70I Excel
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820.75
21 CFR 820 Kim Trautman
: Barbara Richards
43
820.75
21 CFR 820 Kim Trautman
: Barbara Richards
44
5 5 5
21 CFR 820 Kim Trautman
: Barbara Richards
45
FDA
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FDA
21 CFR 820 Kim Trautman
: Barbara Richards
46
820.75 820.75
21 CFR 820 Kim Trautman
: Barbara Richards
47
21 CFR 820 Kim Trautman
: Barbara Richards
48
21 CFR 820 Kim Trautman
: Barbara Richards
49
21 CFR 820 Kim Trautman
: Barbara Richards
50
820.100 CAPA
820.100
2008
CAPA
21 CFR 820 Kim Trautman
: Barbara Richards
51
FDA 43s
820.100
CAPA
21 CFR 820 Kim Trautman
: Barbara Richards
52
ISO 9000
21 CFR 820 Kim Trautman
: Barbara Richards
53
820.100
21 CFR 820 Kim Trautman
: Barbara Richards
54
21 CFR 820 Kim Trautman
: Barbara Richards
55
5 500
100% 20% 80%
21 CFR 820 Kim Trautman
: Barbara Richards
56
CAPA
21 CFR 820 Kim Trautman
: Barbara Richards
57
CAPA
FDA 820.198
21 CFR 820 Kim Trautman
: Barbara Richards
58
CAPA
FDA
21 CFR 820 Kim Trautman
: Barbara Richards
59
21 CFR 820 Kim Trautman
: Barbara Richards
60
FDA FDA ISO
21 CFR 820 Kim Trautman
: Barbara Richards
61
FDA
CAPA
21 CFR 820 Kim Trautman
: Barbara Richards
62
FDA
FDA
FDA FDA
FDA
QSITQSIT
FDA
21 CFR 820 Kim Trautman
: Barbara Richards
63
FDA FDA QSIT
FDA
QSIT
820 PMA HDE
21 CFR 820 Kim Trautman
: Barbara Richards
64
FDA
FDA
21 CFR 820 Kim Trautman
: Barbara Richards
65
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