Principal Scientist II AbbVie North Chicago, Illinois
This presentation will introduce the audience to the new ICH Q14 guidelines, which advocate for a lifecycle approach to analytical procedure development and management. The session will begin with a comparison of the traditional practices under ICH Q2(R1) and the modern framework proposed by ICH Q14, highlighting the key differences and benefits. It will cover the core elements of AQbD, such as the Analytical Target Profile (ATP), knowledge management, analytical risk assessment, and performance monitoring. By understanding these elements, participants will learn how to apply a risk-based approach to analytical development, resulting in enhanced method understanding and increased regulatory flexibility. The session will also provide practical strategies for implementing these principles in day-to-day operations, based on real-world examples and case studies. Finally, it will discuss potential challenges and solutions for adopting this modern framework, emphasizing the need for a cultural shift within organizations to fully realize the benefits.
Learning Objectives:
Describe the key differences between ICH Q2(R1) and ICH Q14 guidelines for analytical procedure development, including the alignment of an Analytical Target Profile (ATP) with a product's control strategy.
Conduct and apply analytical risk assessments to improve method robustness and facilitate post-approval changes within the framework of ICH Q14.
Implement effective knowledge management practices to enhance the transfer, retention, and application of analytical procedure insights, thereby reducing risks and increasing efficiency in lifecycle management.
