Improving Analytical Method Performance Through Quality Risk Management and a Design of Experiments Approach

04 Sep 2019

It is now widely recognized that applying Quality by Design approaches to analytical method development (known as AQbD) has many benefits. AQbD is a science-based risk management approach to developing robust methods by identifying critical method parameters (CMPs) through risk assessment. This approach emphasizes the identification of the sources of variability, and their impact on method performance. By controlling these factors, the variability is reduced thus leading to more robust methods. Typically, a design of experiments (DOE) approach is applied to identify and evaluate the effect of the most influential method parameters and any interactions between them.

In this webinar, Tran Pham, Business Development Manager and Joseph A. Turpin, Director, Chromatography Products and Services from S-Matrix Corporation, will describe the following:

• AQbD and regulatory views
• Examples of DOE in AQbD and benefits
• Case studies demonstrating software assisted AQbD method development

• Benefits of addressing method challenges via risk assessment and design of experiments (DOE) approaches
• Improvement of method robustness and performance with a DOE approach and QbD method development software
• Current thoughts around AQbD from the USP, FDA and ICH

• Method developers and analytical scientists interested in learning how to improve method performance and ease method transfer
• Managers interested in reducing the cost of poor-quality methods