Tuesday, July 22, 2025
8:00 AM PST / 11:00 AM EST

The FDA recently published ~200 Complete Response Letters (CRLs) as part of a new transparency initiative. Over 90% were previously published in drug approval packages, and Redica Systems (in partnership with PDA) already performed a comprehensive analysis of GMP-related CRLs from 2022 to 2024.

Please join us as we present our updated CRL analysis, where we will review the following:

  • Redica Methodology to identify the FDA inspection for the CRL from the drug approval package
  • Top 483 observation issues related to the CRLs  through observation cluster analysis
  • CRL inspection risk model based on the observation cluster analysis and relevant inspection metadata
Speakers:

Michael de la Torre

CEO, Redica Systems

Yelena Ionova

Sr. Manager Data Strategy and Analytics

If you have trouble registering, please contact events@redica.com.