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ValidNMR Workshop 2019

On March 7, 2019, approximately 65 people convened at the Validation Workshop to discuss NMR Validation with a focus on the proposed new USP chapter “The Analytical Procedure Lifecycle”. Contained here are the most common questions we have received from this workshop.
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Kristie Adams
Question 11: Should instrument vendors supply you with QbD tools or analysis for you to use? Or is it more appropriate for this to be done independent of vendors?
By Kristie Adams, Nov 04, 20 
  ValidNMR Workshop 2019
0
343
Kristie Adams
By Kristie Adams
4 years ago
Kristie Adams
Question 10: There is so much terminology to learn that is nearly identical, I believe this confuses people. Is there a way to simplify?
By Kristie Adams, Nov 04, 20 
  ValidNMR Workshop 2019
0
284
Kristie Adams
By Kristie Adams
4 years ago
Kristie Adams
Question 9: What are the parameters which make a NMR experiment quantitative?
By Kristie Adams, Nov 04, 20 
  ValidNMR Workshop 2019
0
297
Kristie Adams
By Kristie Adams
4 years ago
Kristie Adams
Question 8: How can you measure phase error? How is “perfect” defined?
By Kristie Adams, Nov 04, 20 
  ValidNMR Workshop 2019
0
365
Kristie Adams
By Kristie Adams
4 years ago
Kristie Adams
Question 7: What do you find to be the main bottleneck to validating software? Is it always the same?
By Kristie Adams, Nov 04, 20 
  ValidNMR Workshop 2019
0
306
Kristie Adams
By Kristie Adams
4 years ago
Kristie Adams
Question 6: What are differences between GxP and ISO 17025? How many of us are GxP versus ISO 17025?
By Kristie Adams, Nov 04, 20 
  ValidNMR Workshop 2019
0
396
Kristie Adams
By Kristie Adams
4 years ago
Kristie Adams
Question 5: Can “linearity” be established as part of OQ/PQ?
By Kristie Adams, Nov 04, 20 
  ValidNMR Workshop 2019
0
340
Kristie Adams
By Kristie Adams
4 years ago
Kristie Adams
Question 4: What is the difference between a validated technique and a validated method?
By Kristie Adams, Nov 04, 20 
  ValidNMR Workshop 2019
0
364
Kristie Adams
By Kristie Adams
4 years ago
Kristie Adams
Question 3: For this community, should the most useful overall test not be with a purity sample having a known result?
By Kristie Adams, Nov 04, 20 
  ValidNMR Workshop 2019
0
261
Kristie Adams
By Kristie Adams
4 years ago
Kristie Adams
Question 2: Is uncertainty in mass on a balance a random effect or the tolerance for a bias that would impact all weighing?
By Kristie Adams, Nov 04, 20 
  ValidNMR Workshop 2019
0
211
Kristie Adams
By Kristie Adams
4 years ago
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