Founder & CEO PORTRETT PHARMACEUTICALS LLC Wilmington, North Carolina
This presentation will provide practical ways to implement the guidance on lifecycle management. Implementation of method lifecycle management is not commonly performed or integrated into the development process even though the agencies are expecting it to be.
Following an Assay and Related Substances method from development to commercial, we will provide practical ways to develop and implement an Analytical Target Profile, fit for purpose validation strategy and method transfer design. Routine use and performance monitoring will also be discussed. Finally, implementing method updates and lifecycle management such as post approval changes and method improvements will complete the talk.
Learning Objectives:
Develop an Analytical Target Profile (ATP) and use it to drive knowledge-driven method development.
Define an acceptable method operable design region (MODR) and know how it differs from typical robustness.
Set meaningful system suitability criteria and how to trend precision and accuracy over time to help with practical method improvements.
