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.
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. It will provide guidance on how to determine the who, what, when, where so that you can figure out the how and why. It will also provide guidance on how to write your investigation story so that manufacturing and regulatory bodies will be able to follow the investigation coming to the same how and why that you did.
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. It will provide guidance on how to determine the who, what, when, where so that you can figure out the how and why. It will also provide guidance on how to write your investigation story so that manufacturing and regulatory bodies will be able to follow the investigation coming to the same how and why that you did.
Areas Covered in the Webinar:
- 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.
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
Course Provider
Gerry O Dell,
