Wait...Do We Really Need to Validate Our Labeling?

You might be thinking, “Validation? That’s for processes, not labeling. Ours is reviewed, approved, and tracked in our QMS. The FDA’s seen it all!” But here’s the twist: what happens when a product family that’s been on the market for over a decade - with countless line extensions and updates - gets pulled into a CAPA or inspection, and you don’t have objective evidence that the labeling is clearly understood by the end user?

That’s where label validation comes in. In this session of the Let's Talk Labeling speaker series, we’ll explore real-world scenarios where validation became a critical need, and how to be prepared before the audit spotlight hits. Whether your labeling has been stable for years or it’s constantly evolving, this is your chance to learn how to uncover hidden risks and build a solid validation approach.

What You’ll Learn:

• Common triggers that could require labeling validation, even after approval
• How to identify high-risk areas in your device portfolio
• A practical framework for developing a labeling validation protocol
• Tips for executing and documenting your validation effectively
• What regulators actually want to see during audits or CAPAs

Who Should Attend:

• Labeling, Regulatory Affairs, and Quality professionals—especially those responsible for CAPA response or remediation
• Anyone tasked with lifecycle management of legacy product labeling
• Medical device professionals who love digging into the nitty-gritty of label content, usability, and compliance

Speakers:

• Chris Heckert, Consultant, Labeling Solutions, Network Partners Group