Date d'enregistrement: October 28 2014

Duration: 56 minutes 25 seconds

This webinar deals with the routes of verifying laser diffraction instrument performance dealing with the optical set-up, software, and dispersion units. 

Who should attend?

Anyone involved in the verification of laser diffraction equipment. This could include quality control personnel, service engineers, applications engineers but most important, senior management especially director level, who are solely and ultimately responsible for the level of quality and performance within their organizations.
Table of contents
1. Instrument
01:18
2. Instrument performance verification in laser diffraction
01:08
3. Abstract
00:28
4. Essential reference (“Reference 1”)
00:43
5. Reference 2
00:14
6. Reference 3
00:14
7. Reference 4
00:18
8. What do I need to think about and define before I even attempt a particle size measurement?
02:30
9. In QbD speak…..
01:36
10. What does it cost if you get it wrong?
00:37
11. FDA Warning Letter (“483”)See: http://en.wikipedia.org/wiki/Form_FDA_483
00:48
12. Contrast verification and validation
00:40
13. Fit-for-purpose
00:49
14. Up to date!
00:22
15. USP <1058> [From: Chapter 1 Reference 1]
00:59
16. USP <1058> Analytical Instrument Qualification
00:27
17. USP <1058> Analytical Instrument Qualification
00:47
18. 4 stages [From: Chapter 1; Reference 1]
00:06
19. Parameters [From: Reference 1] – note ‘validation’
00:41
20. FDA – this is into PQ
00:49
21. Reference 2
00:40
22. Who does it [From Reference 1]
01:00
23. From Reuter (Reference 3)
00:31
24. The (Bob) McDowall analogy http://www.rdmcdowall.com/
00:30
25. The FDA perspective (the PQ part)http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM359266.pdf
00:32
26. FDA
00:26
27. FDA
00:19
28. FDA guidance – February 2014
00:48
29. FDA Guidance - Decision Tree 3
00:44
30. Remember!
01:03
31. Validation Master Plan (VMP)
00:58
32. Validation Master Plan (VMP)
00:39
33. IQ/OQ – Installation and Operation Qualification
01:18
34. USP <1058> Analytical Instrument Qualification
00:48
35. What is the IQ/OQ limited to?
01:13
36. What is the PQ?
01:31
37. OQ/PQ
01:26
38. PQ – Performance Qualification
00:39
39. What makes the first stage of the PQ difficult to perform?
01:20
40. What characteristics of the material should be modeled?
01:06
41. Standard Materials for verification in particle size analysis
01:26
42. Primary verification
00:58
43. Historical: reticle - basis of ASTM E1458 - 92
00:36
44. Repeatability/reproducibility - reticle
00:14
45. Hardware onlyReticle – ASTM E1458-92
00:51
46. ISO Guides
00:45
47. Thermo Scientific
00:22
48. Whitehouse Scientific
00:26
49. LatexLatices
00:27
50. Latex - examples
00:42
51. Stable samples
00:32
52. Stable samples
00:25
53. Why are 3 latex materials sufficient to prove the instrument optics?
01:00
54. MS2000 Data Point
00:11
55. Why don’t latices challenge sample dispersion units?
00:29
56. PQ – Performance Qualification - Second Stage
00:27
57. Secondary verification – PQ really
00:39
58. Internal standards
00:26
59. QAS
00:22
60. QAS – instrument verification
00:13
61. QAS/latex – instrument verification
00:36
62. QAS and latex – instrument verification
00:07
63. Malvern engineers are trained in this
00:24
64. What do I do in the event of a failure? How much can you afford to lose?
00:59
65. Design of ExperimentLogical Method Development
00:35
66. Software verification/21 CFR 11
00:22
67. 21 CFR 11 http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm
00:17
68. 21 CFR 11 http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm
00:33
69. 21 CFR 11 http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm
00:26
70. 21 CFR 11 http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm
00:27
71. TickIT
00:39
72. Laser diffraction verification – ISO 13320:2009
00:43
73. Laser diffraction verification – USP <429>
00:33
74. Previous relevant webinars
00:32
75. Kiitos ja kysymykset
00:26
76. Contact Information
01:27
77. Contact Information
02:43