Back to: FDA-CRCG Mastering Particle Size Analysis Workshop
About
This session provides a comprehensive overview of DLS technology, exploring its fundamental principles and practical applications in particle size analysis. Industry and regulatory scientists will delve into the current challenges associated with analyzing and assessing particle size studies, particularly in the context of supporting regulatory approvals. The session will also cover critical aspects of method validation and highlight common deficiencies observed in regulatory submissions, offering valuable insights for both researchers and industry professionals.
Presentations
Dynamic Light Scattering Theory and Practice
Jeffrey Clogston, PhD Principal Scientist
Physicochemical Characterization Section Head, NCL
Regulatory Perspectives: Method Validation and Common Deficiencies
William Smith, PhD Research Scientist
DPQR V, OPQR, OPQ, FDA