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.

Why Should You Attend:

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.

At times, the root cause is easily identified and the investigation is conducted swiftly. However, when the root cause cannot be easily assessed by initial review, it can be frustrating to determine the appropriate path for the investigation. There may be multiple potential avenues of exploration.

This webinar will explore successful approaches to laboratory investigations and also explore approaches which may have potential for pitfalls. There is often a natural tendency to quickly focus on a potential cause and attempt to build a corrective or preventive action based on this. At times, there is more than one root cause or the root cause is not the obvious or first issue discovered.

Learning Objectives:

To understand the requirements for investigations when dealing with pharmaceutical drug substances and products; to understand how to effectively control and conduct a laboratory investigation for unknown causes.