Laboratory Compliance 2012 - Laboratory Investigations for Out of Specification Results

This 90-minute webinar on laboratory investigations will explore successful approaches to laboratory investigations of out of trend results and also explore approaches which may have potential for pitfalls.

When an out of specification or out of trend result is obtained on an active pharmaceutical ingredient or a pharmaceutical product, both ICH and CFR guidances indicate a need for investigation. These documents do not give instruction, guidance, tools or expectations as to how an issue should be resolved.