Prachi Narayan

Company: Independent Expert

Job title: Global QC

Seminars:

Establishing Robust Acceptance Criteria for Improved Product Quality 2:00 pm

Establishing acceptance criteria for cell therapy products is crucial for ensuring safety and efficacy by defining standards for parameters like cell viability, identity, potency, and stability during development and testing. However, this process is challenging due to the complex nature of living cells and the lack of standardized methods. While regulatory guidelines provide frameworks, their…Read more

day: Workshop F - Quality Control

Strategies & Designs for Overcoming Product Instability in Quality Control for Streamlined Regulatory Approval 8:30 am

Ensuring the stability of cell therapy products is essential for their safety, efficacy, and regulatory approval. However, detecting and addressing product instability poses significant challenges. This workshop will delve into innovative strategies and methodologies to navigate the complexities of product instability in cell therapy stability studies. From determining critical stability parameters to leveraging advanced analytics,…Read more

day: Workshop B - Quality Control