June - Warning Letter Wednesday (WLW)

​FDA Validation Failures: What You Need to Know

​Over 31% of FDA warning letters sent to drug manufacturers in 2024 pointed to problems with validation. These included issues with process validation, cleaning, analytical methods, and computer systems. In this month’s session, we’ll break down the most common problems, explain what the FDA is really looking for in your documentation and execution, and walk through real examples of CAPAs that worked.

​You’ll leave with a clearer understanding of how to tighten up your validation approach and steer clear of the red flags that trigger inspections. Whether you're building protocols or handling the fallout from findings, this session will give you practical tools and insights from people who’ve actually done the work.

​Guest Speakers:

• ​​Robert Perks, Director of Digital Solutions at Performance Validation, brings over two decades of experience leading digital transformation, AI, and data analytics initiatives in the pharmaceutical industry. He serves on multiple industry committees focused on innovation and regulatory compliance.
  

• ​​​Dr. Ligia Zubik, Director of Quality at Global Key Solutions, has over 20 years of experience leading regulatory compliance and inspection readiness at major pharmaceutical companies.

​Whether you're new to the regulatory world or a seasoned professional, WLW offers a collaborative space to stay sharp and stay compliant. Bring your team and your questions!