Clinical Compliance 2011 - How to investigate environmental monitoring excursion limits

Why Should You Attend:

Medical products are manufactured in environments that are designed to control the level of viable and non-viable particulate and these environments must be monitored to establish that the control measures are continuing to perform acceptably including the impact to product bioburden. You need to establish appropriate limits for ongoing monitoring so it is critical that you know how to set these limits. But once these limits have been set it is also critical for you to know what actions need to be taken to determine if there is product impact or other implications to the manufacturing process when the monitoring results exceed these defined limits.

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