Kristyna Aviles
Sr Director of Quality Systems and Compliance List Biological Laboratories Inc
Seminars
Tuesday 10th November 2026
Advancing Live Biotherapeutic Products: A Quality and Compliance Perspective on Development and Manufacturing
11:00 am
- LBPs present unique challenges for quality risk management including process control and monitoring, change management, evaluating impact of an event, and mitigating environmental risks
- Living nature of the products introduce unexpected risks to product quality, and complexity in demonstrating compliance and ensuring batch consistency
- Collaboration between Quality Assurance and Development and Manufacturing is key to identify, mitigate, and respond to these risks
- Maintaining consistent product quality and upholding quality standards