The increasing number of FDA 483 observations related to smoke studies eludes to a gap in understanding the science, methodology and the purpose behind this important contamination control tool. Airflow visualization is a science not unique to the pharmaceutical industry. The purpose of smoke studies is to characterize and map airflows to detect any deviant or questionable airflow patterns.
These myriad smoke study related observations are indictors of the regulator’s suspicion of contaminated product or data integrity. The recent scrutiny regarding airflow visualization reflects a more astute regulatory body that understands the effect of cleanroom design and airflow on product quality.
Airflow visualization has evolved from a simple test with some videos to becoming a critical component of a holistic contamination control strategy. Airflow visualization, if executed and documented correctly, provides a tool to optimize the contamination control effect of clean air in conjunction with material and operator movements.
This session will dissect recent regulator’s comments and observations and explain why the technology and methodology are crucial for detecting inappropriate airflows.
Which industries does this webinar apply to?
Pharmaceuticals, Biotechnology, Medical Device, Cell and Gene Therapies and Pharmacies
Who will benefit?
Quality Assurance, Quality Control, Microbiology, Engineering, Facilities, Validation, Manufacturing and Training
Time of event
11:00am to 12:00pm EST
8:00am to 9:00am PST
Webinar login information will be sent to registered attendees 48 hours prior to webinar start