Missing or inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in warning letters from the U.S. Food and Drùg Administration (FDA). While most companies do have procedures in place, these are not adequate—or are not followed.
Join pharmaceutical consultant Danielle DeLucy in this live webinar as she guides you through the entire process from detection of an out-of-specification result to informal and formal laboratory and batch investigations.
After attending this audio event, you will know the FDA’s requirements for handling OOS results, phase I and II lab and full-scale investigations, Out Of Trend (OOT) investigations, and common pitfalls during OOS investigations.
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Read more
Follow Us On:
We hope you found this message to be useful. If you don’t wish to receive any further communication, please click the unsubscribe link below. Your request will be processed within 10 days. Audio Educator | 2222 Sedwick Rd, Durham NC 27713 | 1-866-458-2965 This message has been sent by Audio Educator.