Nitrosamine Risk Assessment: Adapting to the Latest Regulatory Expectations
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Nitrosamine Risk Assessment Adapting to the Latest Regulatory Expectations
Nitrosamine impurities continue to challenge pharmaceutical companies. This webinar will help you understand the regulatory framework, perform effective risk analysis using a clear, science-based, and practical approach.
March 4, 2026
1h
Pharma
English
Proactively identify and manage nitrosamine risks
Nitrosamine impurities have become a critical and ongoing challenge for the pharmaceutical industry. Regulatory expectations continue to evolve, acceptable exposure limits**(AELs)**are being reassessed based on evolving toxicological evidence.
In this webinar, our experts will explain why nitrosamines should remain a priority for pharmaceutical organizations and how the regulatory framework is shaping current and future compliance requirements.
You will gain clear insight into the data and inputs needed to perform an effective nitrosamine risk assessment (NRA). We will also explore the critical factors that influence nitrosamine formation and how to interpret assessment outcomes to define appropriate actions.
The session concludes with practical case studies and mitigation strategies, helping you translate regulatory and toxicological concepts into actionable steps for risk minimization.
What you'll learn
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Understand what nitrosamine impurities are and why they pose a critical risk to pharmaceutical products.
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Explore the regulatory landscape, including past developments, current expectations, and upcoming trends.
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Identify the key data and inputs required for an effective nitrosamine risk assessment.
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Evaluate critical risk factors and interpret assessment outcomes to support decision-making.
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Discover practical case studies illustrating strategies to prevent and mitigate nitrosamine formation.
Register now and strengthen your approach to nitrosamine risk management.
Register here
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Who should attend?
- Quality Assurance(QA) and Quality Control (QC) professionals are responsible for ensuring product compliance
- Regulatory Affairs(RA) professionals involved in regulatory strategy, submissions, and interactions with regulatory authorities
- CMC, manufacturing, and technical operations teams supporting nitrosamine risk assessments and mitigation strategies
- Technology Transfer professionals involved in process and product knowledge transfer across development and manufacturing stages
- Formulation and Pharmaceutical Development (R&D) teams involved in product and process design with potential impact on nitrosamine risk
Speakers
Our speakers bring hands-on experience from toxicology, regulatory compliance, and pharmaceutical development. They will translate complex scientific and regulatory requirements into practical guidance that you can apply in your daily work.
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Pablo Palomar
Toxicology Consultant
Pabloholds a degree in Chemistry and a Master’s degree in Organic Chemistry from the Autonomous University of Madrid (UAM). He currently works as a Toxicology Consultant at QbD Group, with a strong focus on nitrosamine-related regulatory requirements.
With over five years of experience in organic synthesis and drug development, he has worked in multiple research laboratories and developed hands-on expertise in a wide range of analytical techniques.
Natalia Herrera
Global Toxicology Liaison
She holds a PhD in Pharmacy from the University of Medical Sciences of Costa Rica and a Master’s degree in Drug Research, Development and Innovation from the University of Navarra. With a strong background in business development, she previously worked at a preclinical CRO, where she played a key role in driving growth and establishing strategic partnerships.
Her professional experience also includes roles as a Medical Sales Representative at several companies, including Abbott. In addition, she has gained valuable experience in quality assurance through her work at Pfizer and other pharmaceutical manufacturing sites, ensuring compliance with industry standards.
Worried about Nitrosamine compliance?
Our experts provide end-to-end assessments, AI calculations, and tailored NRA reports to keep your products safe and compliant.
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