Continued Process Verification and Process Monitoring

DESCRIPTION:

FDA's Process Validation Guidance emphasizes the importance of continual assessment of process performance and product quality throughout the product's lifecycle. By combining process control and improvement, you can align with the principles of ICH Q8 (R2) and the FDA's guidance for continued process verification, continuous improvement, and life cycle management. Join us as we present a structured and disciplined "Quality by Design" approach to help you achieve this objective.

While the pharma and biotech industries have focused extensively on the concept of the QbD "Design Space," less attention has been given to implementing robust "process control" systems that ensure consistent quality product outcomes. Our presentation will shed light on the critical need for process control to maintain process stability and drive consistent production of high-quality products. We will explore the routine analysis of process data at various levels to assess stability and capability, both within each batch and across different batches over time. Our system will be presented in detail, addressing important questions and challenges that arise. Furthermore, we will discuss the connections between this system and process robustness, offering valuable insights for process optimization.