QbD is a scientific, risk-based, holistic and proactive approach to product development with predefined objectives. It emphasizes product and process understanding and process control and is based on sound science and quality risk management. QbD is also about ensuring that products have the required safety and efficacy through process control using quality risk management and knowledge management. Building reliable, efficient, and robust cost saving methods supports product development, production, and evaluation to ensure that quality and safety standards are met.
Why QbD is Important for Analytical Methods
What are the drivers for adoption of QbD concepts in the Pharma Industry and how can these concepts be applied to help ensure analytical methods are developed that are robust and rugged. What are the implications QbD approaches have on how analytical methods are validated and why are some of the key concepts needed, including Analytical Target profile (ATP), the importance of management of variation and the key aspects involved in lifecycle management of analytical methods.
This eSeminar took place in two 2-2.5 hr sessions in May 2014. Click here for on-demand view: Registration