July Warning Letter Wednesday: Unannounced FDA Inspection?

Are You Ready for an Unannounced FDA Inspection?

Why Inspection Readiness Isn’t Optional in 2025

In 2025, the U.S. FDA intensified its scrutiny of pharmaceutical operations, with a majority of U.S.-based GMP inspections being unannounced.

Disorganized documentation, inconsistent SOP execution, and unclear inspection roles. These breakdowns aren’t just procedural; they’re costly and more critical in today's environment.

To help pharmaceutical leaders stay inspection-ready, GKS is sponsoring several speakers for this month's Warning Letter Wednesday.

This high-impact webinar brings clarity, strategy, and real-world examples to the forefront of compliance preparation. Whether you're in QA, compliance, or operations, this session is designed to prepare your team for those unexpected moments that require immediate attention.

What You'll Learn

• Top Triggers for Unannounced Inspections: What prompts the FDA to arrive without warning, and how to avoid red flags.
• The Critical First 30 Minutes: Understand what investigators look for the moment they arrive.
• Best Practices for Response Readiness: From team structure to document control, learn how to orchestrate a calm, coordinated audit response.

Meet the Experts

• Daniel Barreto, President of PharmQ Global Consulting, provides strategic and tactical consulting across pharma operations.
• Martin Orcoyen, President of ISPE Argentina and COO Sudamérica at QUALIPHARMA, brings over 20 years of quality and regulatory insight.
• Dr. Ligia Zubik, Director of Quality at Global Key Solutions, is a leader in inspection readiness across top pharma firms.
• Kasia Grzelecka, a digital operations expert with 15+ years in procurement and regulatory process improvement.

Why WLW?

• Identify and close potential regulatory gaps
• Automate compliance tracking
• Analyze trends from thousands of past inspection records

Register Now