Course overview
Nitrosamine regulations are the most impactful change to our industry in recent years, affecting 30% of current and new products, including generics. Regulatory expectations have changed frequently and vary globally. In this webinar, we will discuss the major requirements and strategies. Those new to the subject and those growing their nitrosamine team will find value in seeing the entire picture. Experienced Small and Medium-sized Enterprises (SMEs) will receive detailed instructions for common pain points, like risk assessments.
CPD Hours: 6
Course Content
- Day 1
- History and background
- Classes of nitrosamines
- Regulatory update
- Team building
- Risk assessments
- At risk structures
- Limit determination
- Day 2
- Nitrosation Assay Procedure (NAP) test
- Analytical instruments and methods
- Control strategy
- Remediation
- Post approval changes
- Where are we going? Future state and unanswered questions
Speakers
Jason Brown
Jason Brown brings a wealth of knowledge and practical experience to his role as Senior Analytical Sciences Manager at Adare Pharma Solutions, where he serves as the global nitrosamine subject matter expert. He has led Adare’s innovative approaches to understanding nitrosamine formation, measurement, and mitigation to ensure regulatory compliance internally and for our customers. Jason has led numerous dialogues on the subject of nitrosamines through panel discussions, webinars, posters, articles, and regular contributions to the USP Nitrosamine Forum. Jason has a BS in Chemistry from George Fox University.
