Managing Director and CEO Pharmalytik Newark, Delaware
Analytical method lifecycle management is expected to ensure methods are scientifically sound, fit-for-purpose, and consistently deliver reliable data from development through routine use. Compendial and global frameworks emphasize a lifecycle approach that integrates method development, validation, transfer, and ongoing performance monitoring within an effective quality system. The session will focus on establishing Analytical target profile, maintaining method control strategies, detecting variability or drift, and continuing improving method performance.
Learning Objectives:
Define analytical target profile aligned with regulatory expectations
Apply lifecycle approach across development, validation, and routine use
Establish robust method control strategies ensuring consistent performance
Monitor method variability, detect drift, and maintain data integrity
Implement continuous improvement for sustained analytical method performance
