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.
Benefits of attending
- Enhance your understanding of current regulatory framework and recent changes
- See the full scope of work for your team members to understand how their part fits with the whole
- Learn best practices for risk assessments
- Inform next steps when your product is near or above regulatory limits through remediation, control strategies, and new research
- Example products guide the way to practical understanding
Certification:
- CPD: 6 hours for your records
- Certificate of completion
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
Who Should Attend
This course will benefit nitrosamine decision makers and those who can benefit from a broader understanding of the full picture of nitrosamines in regulatory affairs, sales, quality, and analytical departments.
