|
What is the probability of nitrosamine formation during DP production
|
|
6
|
572
|
April 26, 2022
|
|
200+ USP Monograph w/ Tertiary amines
|
|
1
|
472
|
April 5, 2022
|
|
How Relevant is a 'check list'?
|
|
0
|
339
|
March 2, 2022
|
|
FDA Warning letter <Nitrosamine or NOT>
|
|
0
|
447
|
February 14, 2022
|
|
Update of the CMDh's Q&A Document on Nitrosamine Impurities
|
|
2
|
873
|
January 26, 2022
|
|
Nitrosamine Workshop USP / Sindusfarma / ANF ACFB -live discussion
|
|
7
|
1052
|
December 8, 2021
|
|
When minimum information is provided for risk assessment?
|
|
1
|
310
|
November 23, 2021
|
|
Screening vs **Risk Assessment**?
|
|
11
|
600
|
September 7, 2021
|
|
Q&A Nitrosamine SAR working group (23 companies and universities)
|
|
12
|
1499
|
August 25, 2021
|
|
What steps is FDA taking or planing to take, to collaborate with other regulatory authorities to align on expectations for Step 2 confirmatory testing?
|
|
4
|
348
|
July 28, 2021
|
|
Determining structural similarity for read-across
|
|
2
|
350
|
July 8, 2021
|
|
Residual amines and risk assessment - how far do you go?
|
|
2
|
587
|
July 4, 2021
|
|
Are all N-nitrosamines a concern?
|
|
2
|
660
|
June 24, 2021
|
|
Nitrosamine Risk on shared equipment?
|
|
2
|
221
|
June 23, 2021
|
|
How ID all conditions and mechanism of Nitrosamine formations?
|
|
2
|
280
|
June 21, 2021
|
|
USP <1469> goes live Today
|
|
3
|
292
|
June 16, 2021
|
|
Managing The Risk of Nitrosamine Impurities
|
|
0
|
293
|
June 7, 2021
|
|
How to use Purge in Nitrosamine Risk Assessment?
|
|
7
|
656
|
May 26, 2021
|
|
How to do risk assessment in case of multi product facility of API considering cross contaminations?
|
|
0
|
298
|
May 26, 2021
|
|
Risk Assessment & Q(SAR)
|
|
2
|
394
|
May 21, 2021
|
|
Risk Assessment checklist, is that enough?
|
|
0
|
583
|
May 12, 2021
|
|
FDA - Nitrosamine: Where are we now?
|
|
0
|
234
|
April 21, 2021
|
|
FDA Q&A on DMFs and drug substances
|
|
0
|
330
|
April 20, 2021
|