is being presented by Jerry Lanese, President, of The Lanese Group, Inc and airs on Tuesday, September 7th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Inadequate procedures for laboratory out-of-specification (OOS) investigations remains high on the list of FDA observations. Although the FDA's interest in how pharmaceutical firms handle OOS laboratory results began more than 15 years ago, and the Agency has issued a guidance on the topic, OOS procedures and investigations are still a topic of FDA investigator review and findings.
An out-of-specification laboratory observation triggers emotional and political actions that inhibit a productive investigation with a timely conclusion. There is still confusion in the laboratories as to how an out-of-specification result should be handled and investigated. In this audio conference we discuss the investigation that goes on within the laboratory. Although the focus is on the FDA guidance, the discussion includes suggestions for a process that will meet the FDA expectations.
