Join us for our upcoming webinar where we explore the scientific and regulatory challenges of applying ICH M7 Control Options 3 and 4 to manage nitrosamine impurities in pharmaceuticals. Drawing on real-world case studies from the recently published journal article Industrial Case Studies Demonstrating Applicability of ICH M7 Control Options 3 and 4 for Nitrosamine Control, the authors will present evidence-based strategies to justify process-driven control strategies (Option 4) and hybrid approaches (Option 3) for these high-potency impurities. Attendees will gain actionable insights into balancing regulatory expectations, scientific rationale, and practical implementation.
What to expect?
- Authors Mike Urquhart (GSK), Marzia Galli (Merck) and Paula Tomlin (AstraZeneca) will each present on a real-world case study showing how purge calculations could be leveraged for nitrosamine impurity control.
- Jack Yung (Lhasa Limited) will demonstrate the value of using in silico tool Mirabilis to carry out nitrosamine risk assessment.
- There will be a live Q&A following the presentations where attendees will have the opportunity to ask any questions to the speakers.
The webinar will begin at 12pm BST and last for approximately 1 hour. Register today to attend!