From Regulation to Application: Best Practices in Elemental Impurities & Residual Solvent Assessment Webinar
Join our team of specialists for a focused and practical live webinar exploring the critical process of impurity risk assessment in drug substances and finished products. This session will highlight key aspects of ICH Q3C (residual solvents) and ICH Q3D (elemental impurities), providing clarity on current regulatory expectations and strategic approaches to compliance.
With over 20 years of combined experience in the industry and with advanced analytical techniques including GC-GC/MS and ICP-MS/OES, our experts will offer practical guidance supported by real-world case studies. Whether you are developing new products or optimising existing ones, this session will help you strengthen your impurity risk assessment strategy.
What You’ll Learn:
Stay ahead of regulatory demands with insights and actionable takeaways, including:
- Understanding Impurity Risk Assessment:
An overview of assessing elemental impurities (ICH Q3D) and residual solvents (ICH Q3C) in pharmaceutical products. - Regulatory Updates & Expectations:
A review of recent updates and their implications for impurity profiling and risk assessment. - Efficient Assessment Strategies:
Explore analytical techniques and workflows built on over 15 years of GC-GC/MS and ICP-MS/OES experience. - Real-World Case Studies:
Application-focused examples that demonstrate how to interpret and respond to regulatory requirements.
Why Watch?
In an increasingly complex regulatory landscape, understanding how to effectively assess impurities is essential for ensuring product safety, regulatory compliance, and successful market release. This webinar provides a rare opportunity to gain direct insights from experienced analysts who have supported global pharmaceutical programmes for over 15 years. By attending, you will deepen your understanding of ICH Q3C and Q3D requirements, learn how to apply these guidelines to real-world scenarios, and explore efficient, science-led strategies for impurity risk assessment. Whether you are developing new formulations or maintaining the compliance of established products, this session will equip you with the knowledge needed to manage impurity risks with confidence.
Cormica’s mission is to improve patients’ lives by providing comprehensive testing services, enabling clients to launch and release their products safely and rapidly across the world.
With Cormica as your partner, you can confidently outsource your impurity testing to a laboratory with deep regulatory knowledge and technical expertise. Whether you are developing a new drug product, conducting a risk assessment for existing formulations, or responding to updated ICH guidelines, our team is here to support your analytical needs. Contact us to discuss how we can assist with your impurity profiling strategy at sales@cormica.com
Authors:
Yvonne MacLeod
Section Head - Separation Sciences
Yvonne MacLeod leads the Separation Sciences team at Cormica’s UK Bradford site. With over 15 years’ experience in the CRO industry and a strong background in GMP, she is committed to excellence in analytical science. Yvonne and her team routinely deliver efficient, high quality work packages to comply with ICH Q3C with headspace GC-FID and GC-MS available on site.
Daniel Gallagher
Analytical Scientist
Daniel Gallagher has been working in the field of elemental analysis for 9 years having graduated with a BSc in Chemistry and has been at Cormica Bradford within the Physical Characterisation team for 3 years. He has accumulated his expertise with a diverse sample portfolio which bolsters his handling of complex sample presentations and troubleshooting method challenges. Working with pharmaceuticals has always been a passion of Daniel’s, especially drug development work to achieve our vision of improving patients’ lives.