ComplianceOnline, Online Event
2012-09-06
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. This presentation will review best practices for setting bioburden/environmental monitoring limits and the various items that should be included in an investigation to determine the cause of a limit excursion for both viable and non-viable excursions. Who will Benefit: This webinar will provide valuable information to all companies that manufacture medical devices in environments that are controlled and monitored for viable or non-viable contamination. - QA personnel
- Manufacturing Supervisors
- R&D
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