Late-Stage Assay Validation Strategies to Ensure Regulatory Alignment & Commercial Readiness
Time: 1:40 pm
day: Day 1 - Track B - Afternoon
Details:
- Learn how to transition qualified release assays to fully validated methods that meet pivotal and commercial expectations
- Explore key validation criteria robustness, specificity, reproducibility and how to meet them under tight timelines
- Understand how assay maturity and early planning can reduce downstream risks during PPQ and commercialization
