How to Investigate Environmental Monitoring Excursion Limits

This environmental monitoring training will review the best practices for setting environmental monitoring alert and action levels for viable and non-viable data including product bioburden. In addition this webinar will address the responses/actions that should be taken when an excursion in the alert or action level occurs.

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.

Areas Covered in the Seminar:

• Best practices for monitoring and establishing limits.
  • Product bioburden
  • Viable particulate
  • Non-viable particulate
• Do I really need to investigate if the alert limits are exceeded?
• Investigating an alert limit excursion.
  • In the environment
  • On the product
• Who to investigate.
• What to investigate.
• When - what is the appropriate timeline to investigate.
• Where should you look.
• Documenting the investigation story.

For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701504?channel=ScienceDZ