Adoption of Process Analytical Technology: Regulatory Frameworks, Recent Updates, & Industry Support for Use of PAT in Drug & Biologic Manufacturing
- Discussing regulatory challenges and barriers to the adoption of PAT in drug and biologic manufacturing
- Clarifying key expectations and updates in recent FDA, USP and global regulatory guidelines
- Highlighting case studies that illustrate regulatory best practices and lessons learned
- Identifying tools and strategies to align PAT implementation with regulatory expectations during development and lifecycle management