Particulates in Biological products. Why test them and what are the new reporting requirements

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Understand FDA expectation for reporting for sub-visible particulate testing in biologics injectibles and various methods used for characterization of the sub-visible particles.

This webinar addresses recent discussions in the industry related to testing sub-visible particulates in Biologics injectibles. Recent FDA expectations for reporting data will be discussed. Methods for characterization and routine testing of particulates, their advantages and limitations will be discussed. Case studies where the various methods have been used for characterization of the sub-visible particles will be discussed.

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