One-Day Course
Date to be announced; 8:30am – 5:00pm
Dr. Jinjian Zheng, Merck & Co., Inc., Rahway, NJ
COURSE DESCRIPTION
This one-day course provides a comprehensive overview of nitrosamine risk assessment and control in pharmaceutical products. We will review key regulatory guidelines (EMA, FDA) and explore nitrosamine formation mechanism and root cause analysis. We will discuss control strategies, including formulation development and analytical testing with a significant focus on analytical method development for trace-level nitrosamines (both common nitrosamines and NDSRIs) and vulnerable amines as well as nitrite in excipients, and practical strategies for implementing routine testing in a QC laboratory environment. This course is ideal for analytical scientists, formulators, and CMC professionals seeking to manage nitrosamine impurities effectively.
WHO SHOULD ATTEND
Analytical scientists, formulators, CMC professionals.
TOPICS
- Background
a. Safety concerns on nitrosamines in pharmaceutical products
b. Overview of regulatory guidelines - Nitrosamine Risk Assessment and Control Strategies
a. Common risk factors
b. Nitrosamine risks from drug substance
c. Nitrosamine risks from drug product
d. Nitrosamine risks from container closure
e. Control strategy - Analytical Method Development
a. Testing of nitrosamines and amine precursors
b. Testing of nitrite
ABOUT THE INSTRUCTOR
Dr. Jinjian Zheng is a Senior Principal Scientist at Merck with over 20 years of experience in pharmaceutical industry. As a subject matter expert in chromatography, he leads analytical development for nitrosamine risk assessment, root cause analysis and control strategy at Merck. Dr. Zheng specializes in developing and implementing user-friendly analytical methods, including GC-NPD, HPLC-MS, and HPLC-UV. He is an active member of both the IQ Consortium nitrosamine analytical working group and the Lhasa Nitrites Database analytical working group, placing him at the forefront of addressing this critical industry challenge.
