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2 - Airflow Visualization - Using smoke to make things clearer

‐ Mar 13, 2024 12:15pm

Airflow Visualization (“Smoke Studies”) are viewed by inspectors as an important compliance evaluation. But airflow visualization can be more than just a “check box” to avoid a citation, it can be an important tool to help us understand, and ensure, product protection. In this session we will provide an overview of the new ISPE Handbook and training for Successful Smoke Studies; discussing the expectations of both Annex 1 and FDA guidance, common mistakes, observations and the best practices to help you avoid these pitfalls. Whether studies are performed in-house, or outsourced to a third party, this session will give you actionable insights to improve your studies.