Sanitation Break: Legal Interpretation and Industry Practices

Jun 3, 2025 (11:00 AM- 12:00 PM Eastern Time)

Webinar Description

The session will focus on the design and implementation of clean breaks (validation, verification, and trend analysis), the importance of clean breaks for protecting your manufacturing from a risk exposure and liability perspective, and related practical considerations when relying on clean breaks to bracket implicated product, including in recall or other market action situations. Additionally, the discussion will include considerations often addressed by FDA during enforcement situations related to sanitation break justifications. From the sanitation perspective, the session will also discuss alternative ways to conduct sanitation activities during the sanitation break. The goal is to achieve cleaning objectives effectively while reducing the burden of the process.

Learning Objective

1. Understand the FDA regulatory framework relating to establishing and defining a sanitation break, including guidance and industry practices

2. Discuss related practical considerations when relying on clean breaks to bracket implicated product

3. Explore alternative ways to conduct sanitation break and sampling plan.