09:00 am Workshop E:
Delving into the Specifics of Quality Control to Improve Success Rate & Meet Regulatory Requirements
Delving into the Specifics of Quality Control to Improve Success Rate & Meet Regulatory Requirements
Time: 9:00 am
day: Workshop Day Track C P1
Details:
Quality control is a focus for everyone during cell therapy manufacturing and is equally a challenge. Whether it is quality control for manufacturing process or during analytical development, it is something that is ever prevailing and important in improving success rate, increasing safety, and reducing costs. With emerging novel technology, quality control methods need to be updated and you need to ensure it meets regulatory guidelines.
Join this workshop to:
- Set critical quality attributes required for your cell therapy products
- Explore different potency, purity and sterility assays to help maintain product quality
- Validate quality control strategies ahead of time to reduce costs
- Convince regulatory authorities your quality control strategies are better than the traditional ones
- Overcome variability in manufacturing to maintain high quality
