Enhancing the Knowledge Transfer Between Departments

Time: 10:00 am
day: Workshop D


  • Bridging assay transfer from analytical development to quality control
  • Strengthening the link between quality and process development teams: enhancing communication, knowledge transfer, and manufacturing/PD in GMP investigations
  • How/why/when should AD develop additional analytical methods specifically for PD purposes?
  • How does this method differ in Quality standards when the test is performed FIO
  • What is the quality standard for a test method used to justify a process change?
  • Who is responsible for running the lab tests on PD samples?