SCIEX has been at the forefront of bringing innovative MS technologies to its customers and creating platforms to share the expertise of our customers. SCIEX aims to make you more productive with our end-to-end LC-MS/MS solutions and this November we are organizing a virtual Pharma Conclave.

Who should attend:

Individuals with an interest in

  • Impurity profiling strategies for APIs and drug products
  • Pharmaceutical – regulations, methods, and challenges
  • E&L testing and regulations
  • Cleaning validation
  • Pharma regulatory landscape in India and the global context


Agenda

Day 1 - November 24, 2022

Time Topic
3.00-3.05 p.m. Introduction to SCIEX 
3.05-3.30 p.m. Nitroso impurities - current regulatory updates, challenges, and suggested solutions
3:30-3:55 p.m. Nitrosamines, NDSRIs and azido impurities as cohorts of concern in pharmaceuticals
3:55-4.20 p.m. Challenges in quantifying NDSRIs in pharmaceutical drug products
4.20-5.00 p.m.

Panel discussion on nitroso impurities - need gap analysis and directions for the Indian pharma industry 

 

Day 2 - November 25, 2022

Time Topic
3.00-3.05 p.m. Welcome note
3.05-3.30 p.m. Regulatory landscape for extractables and leachables testing
3.30-3:55 p.m. Challenges in extractables and leachables (E&L) study in pharmaceutical
3:55-4.20 p.m. Challenges in equipment cleaning and contamination control of nitrosamines
4.20-5.00 p.m. Panel discussion on E&L regulatory -  landscape, guidelines on pharmaceutical packaging systems

Register now

Speakers

Dr. BM Rao

Partner & CEO at QDOT Associates

Dr. Saranjit Singh

Ex-Dean and HOD, Dept. of Pharmaceutical Analysis, NIPER, Mohali

Dr. Harsha K N

Head - Analytical Characterization at Shilpa Medicare LTD, Dabaspet, Bangalore

Shivkumar Vishwanathan

Director and V.P Marketing at GVS Cibatech Pvt Ltd, Mumbai

Dr. Dama Venugopal Rao

Lead-Structural Characterisation and Analytical Expert- complex injectables at Dr. Reddy's Laboratories