21 CFR 820 Kim Trautman

: Barbara Richards

1

FDA 21 820 21 CFR 820

1997 6 1 1978 GMP

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21 CFR 820 Kim Trautman

: Barbara Richards

2

21 CFR 820

IVD

21 CFR 820 Kim Trautman

: Barbara Richards

3

25 50 500 1000

90 establish 3Ddefinedocumentdo

3D

21 CFR 820 Kim Trautman

: Barbara Richards

4

21 CFR 820 Kim Trautman

: Barbara Richards

5

7 7 C7

FDA

21 CFR 820 Kim Trautman

: Barbara Richards

6

FDA

21 CFR 820 Kim Trautman

: Barbara Richards

7

CEO COO

21 CFR 820 Kim Trautman

: Barbara Richards

8

3 3

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

[

device master records

1978 GMP GMP 1980 MDR FDA

35% 47%

21 CFR 820 Kim Trautman

: Barbara Richards

12

CD 90%

1990 FDA

1990

FDA

50

60

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: Barbara Richards

13

FDA FDA

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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 []

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

820.30I

820.75

820.40

21 CFR 820 Kim Trautman

: Barbara Richards

41

100 1000

820.70 I

CAPA FDA

21 CFR 820 Kim Trautman

: Barbara Richards

42

820.70I Excel

Excel FDA

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

6

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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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