Leading Investigations into Foreign Particulate Matter


In life science industries, foreign particulate matter (FPM) can affect products efficacy but more important product safety. Traditional ways of dealling with FPM are reactive in nature and are not suited to comply with a quality by design approach to manufacturing. This course will provide an overview of current FPM detection techniques and how to couple them with a newer characterization regimen inspired by criminal trace evidence analysis. It guides attendees through the different phases of characterization and how to use these in a holistic proactive program, for FPM issue remediation. Attendees will be challenged by hand-on sessions where they will be responsible for documenting FPM attributes by different inspection methods and by isolating the particulate with provided tools. This type of program heightens efficiency of FPM investigations which ultimatly saves cost by decreasing delayed release time and lost product.

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