RTD Series (No.3) - Nitrosamines, NDSRIs & Azido Impurities
  • Day1
Friday, 16th December 2022

08:00

Registration

09:00

Welcome Address
Sanjay Bajaj, CEO & MD, Glostem Private Limited, India

09:15

Update on Cohorts of Concern in Pharmaceuticals: Opening Remarks by the Moderator
Saranjit Singh, Ex-Professor & Head, Pharmaceutical Analysis, NIPER, Mohali, India

09:30

Chemistry and Complete Mechanistic Understanding to help Control Nitrosamine, NDSRIs and Azido Impurities in API & Drug Products
Vinod Kansal, Former President, Amoli Organics, India

Modification of Manufacturing Process, Avoidance of Solvents that may cause formation of these impurities, like DMF, DMA and amines (inorganic bases), Routine testing for the APIS, excipients and solvents to proper control and check the level of nitrosamines etc.

10:00

Moderated Open Discussion Session 1

10:30

Coffee Break

11:00

Origin and Mitigation Strategies for Nitrosamines, NDSRIs, Azido Impurities in API Synthesis
Narender Rao Somisetti, Vice President, Head - R&D, Metrochem API, India

11:30

Moderated Open Discussion Session 2

12:00

Evolving Challenges with NDSRIs and Suggested Solutions
B M Rao, Partner & CEO, QDOT Associates, India

12:30

Moderated Open Discussion Session 3

13:00

Lunch and Networking

13:45

Cleaning Validation to Avoid NDSRIs and Genotoxic Impurities
Kiran Kota, Quality Head, SMS Pharmaceuticals Ltd, India

14:15

Moderated Open Discussion Session 4

14:45

European Pharmacopoeia Policy on Control of Nitrosamines, Genotoxic Impurities and EP followed Regulatory Recommendations
Ulrich Rose, Former Deputy Head, EDQM, France

15:05

Moderated Open Discussion Session 5

15:30

Addressing the Nitrosamines & NDSRI Challenge using Shimadzu’s UFMS Technology
Dheeraj Handique, Deputy Manager – GC/GCMS Product Marketing, Shimadzu Analytical (India) Pvt. Ltd, India

15:40

Analysis of Cohorts of Concern using Sciex Technology
Pankaj Partani, Application Support Manager, Sciex, India

15:50

Coffee Break

16:10

Open Discussion Session - Expert View-points/Presentations of Personal Views from Delegates

16:40

Summary & Concluding Remarks by the Moderator Prof Saranjit Singh, Ex-Professor and Head, NIPER, Mohali, India

16:50

Vote of Thanks by Dr Sanjay Bajaj, CEO and MD, Glostem, India

17:00

End of the Meeting

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