Marketing Program Manager Agilent Technologies Inc San Ramon, California
The implementation of ICH Q14 and USP < 1220> marks a transformative shift in analytical procedure development, aligning closely with Quality by Design (QbD) principles to promote a lifecycle approach. This presentation explores the critical need for adopting ICH Q14, highlighting its role in enhancing method robustness, regulatory flexibility, and risk-based decision-making. It delves into the integration of Analytical Target Profile (ATP), control strategies, and knowledge management, while addressing the practical challenges faced by industry—ranging from resource constraints to regulatory harmonization. Through case studies and strategic insights, the session aims to equip stakeholders with a roadmap for successful adoption and long-term sustainability.
Learning Objectives:
Explain the key principles and regulatory expectations of ICH Q14 and USP related to analytical procedure development and validation.
Differentiate between the requirements of ICH Q14 and USP, highlighting their similarities, differences, and practical implications.
Apply ICH Q14 and USP guidelines to develop and validate analytical procedures that meet regulatory requirements.
