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Webinar Overview
Meeting FDA and ICH requirements for biologics isn't just about compliance. It's about ensuring product quality, safety, and stability at every stage. However, many organizations struggle with method selection, validation, and regulatory expectations, leading to delays and costly rework. This expert-led webinar provides a strategic approach to optimizing lot release and stability programs that can help you stay ahead of evolving standards.
You'll learn about:
- Selecting the right analytical methods for regulatory approval
- Avoiding common pitfalls in lot release and stability testing
- Understanding how ICH/FDA guidelines impact your testing strategy
- Designing stability programs that balance efficiency and thoroughness
Webinar Presenter
Kasia Marciniak-Darmochwal, PhD
Scientific Director, Analytical Services
Charles River