Speaker:

Marie Mathews

Former FDA CDER compliance officer / Current Principal & CEO at Franklin Mathews Group

Thursday, May 8, 2025
10:30 AM PST / 1:30 PM EST

Join regulatory intelligence expert and former FDA CDER compliance officer Marie Mathews for a data-driven deep dive into the most pressing compliance issues flagged in FDA CDER warning letters throughout 2024—plus a bonus look at early trends emerging in Q1 of 2025.

Whether you work in Quality, Regulatory Affairs, or Site Operations, this session will help you benchmark your compliance practices against the FDA’s most commonly cited deficiencies. Using Redica’s enhanced tools and data, we’ll spotlight real-world examples, recurring failures, and evolving enforcement patterns to help you stay ahead.

Key Highlights​:

  • Top Reasons Manufacturers Received Warning Letters in 2024 and early 2025​ – Uncover the most frequently cited deficiencies—from sterile production controls to repeat failures in deviation investigations and facility maintenance.
  • Targeted Analysis Using Redica’s Ontologies​ – See how we filtered nearly 200 warning letters to focus on those most relevant to prescription drug manufacturers, with breakdowns by facility type (generic vs. non-generic) and product type (API, FDF, sterile).
  • Real-World Case Studies and Hot Topics -​ Explore how companies fell short—and what the FDA expected in response. Topics include:
    • Data integrity failures (falsified records, backdating, inadequate computer controls) and fraud among suppliers, manufacturing partners, and competitors​
    • Sterility Concerns ​
    • Rare Issuance of a Warning Letter in the Cell and Gene Therapy Space​
    • Tips on what not to do in your response ​
    • API manufacturer issues flagged in early 2025
  • Warning Letters Without Prior Inspections​ – Discover a growing enforcement trend: Warning Letters issued without recent inspections—and the triggers behind them
  • Actionable Takeaways​ – Walk away with practical recommendations to strengthen your quality systems and reduce enforcement risk.

 

This webinar is for current Redica Systems customers. If you have trouble registering, please contact events@redica.com.