Step-by-Step Process for Successful Sterility Failure Investigations
Duration: 75 Minutes
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There is no one size fits all investigation for microbial contamination. Microbiological testing covers a wide range of products, processes and environments, therefore representative samples from each of these categories forms the basis of what gets investigated. The role of QC microbiology in the identification and investigation of various results from manufacturing areas and finished product testing is extremely important. When the need for an investigation arises, it is common for a cross functional team to convene involving all levels of management from various departments - quality control chemistry and microbiology, manufacturing, quality assurance, and, facilities and engineering.
03/14/2018 11:30 AMTraining Topic: Step-by-Step Process for Successful Sterility Failure InvestigationsInstructor: Danielle DeLucy
Objectives of the Presentation
FDA regulations and guidance on sterility failure investigations
Stages of investigation: Lab investigation vs. manufacturing investigation
Tools to use to help determine root cause
How to categorize sterility results
How to address impact to lots affected
Areas, parameters and variables to investigate as part of the investigation
Proper documentation of the investigation
CAPA plans that address root cause
Why Should you Attend
One of the important elements of the investigation is to decide which failing result comes from the appropriate category: product, process or environment. Once you determine where the failure has occurred, the investigation begins into finding out why it failed and how to correct it.
In this session, our speaker will describe the actions that should be taken when a sterility test failure occurs. What happens when a suspect microbial result is reported? What does it look like, how do you react? Danielle will answer these questions and review when it is appropriate to investigate a result that may seem out of the ordinary.