Upcoming August - Warning Letter Wednesday: How to Prevent Warning Letters & Findings

What Steps Do You Take To Prevent Warning Letters & Findings?

Why Prevention is Critical in 2025

The FDA continues to intensify its oversight of pharmaceutical operations, and 483s and Warning Letters (WLs) are among the most common outcomes of inspections. Many of these findings trace back to gaps in Quality Management Systems (QMS), ineffective CAPA processes, and inconsistent documentation practices.

These issues aren’t just procedural, they can delay approvals, harm credibility, and result in significant financial costs.

This month’s Warning Letter Wednesday, sponsored by GKS, will share practical strategies, case studies, and data-driven insights to help you stay inspection-ready and avoid costly regulatory setbacks.

What You'll Learn:

• Proactive quality planning (AQP & FMEA)
• Effective CAPA and root cause analysis
• Lessons from real FDA case studies

Meet The Experts:

• Bill Levinson, Expert in lean manufacturing, supply chains, and quality systems, focused on efficiency that drives profits and reduces costs.
• ​​Daniel Barreto, President of PharmQ Global Consulting, provides strategic and tactical consulting across pharma operations.
• Dr. Ligia Zubik, Director of Quality at Global Key Solutions, is a leader in inspection readiness across top pharma firms.

Why WLW?

• Avoid costly citations and delays
• Build confidence for inspections
• Stay ahead of regulatory expectations