Establishing Robust Acceptance Criteria for Improved Product Quality
Time: 2:00 pm
day: Workshop F - Quality Control
Details:
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 application requires careful consideration of each product’s unique characteristics. Developing robust acceptance criteria is essential for maintaining product quality.
Join us to:
- Understanding the regulatory guidelines and expectations for establishing acceptance criteria in QC processes, ensuring compliance with industry standards and regulatory requirements.
- Learning practical methodologies, strategies, and risk assessment techniques for defining acceptance criteria, enabling participants to implement effective QC protocols tailored to their specific product development needs.
- Gaining insights into industry best practices, continuous monitoring and evaluation and challenges related to acceptance criteria establishment, providing valuable guidance for optimizing QC processes and enhancing product quality and safety.
