FDA Guidance 2020 - "Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations Training"

Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. It is clear that regulatory investigators throughout the world are looking at laboratory operations very closely.
The objective of this live training webinar is to develop an understanding of how a compliant laboratory handles the investigation of OOS test observations and how the laboratory interfaces with other units through the laboratory investigation process.
• The requirements for laboratory OOS investigations.
• Latest Regulatory expectations.
• The laboratory OOS investigation process.
Speaker:
John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System.