Optimizing Analytical Validation for Commercialization Success in Product Development
Time: 9:30 am
day: Conference Day Two
Details:
- Exploring methods to strategically validate assays, minimizing the number required for commercialization while ensuring regulatory compliance.
- Discussing the transition towards PAT to accelerate testing timelines, with a focus on stability assessments and early data acquisition.
- Investigating innovative approaches to obtain stability data earlier in the manufacturing process, enabling expedited release of the final drug product.