Failure or OOS Investigation for environmental monitoring (viable and nonviable)

FACT: 
Medical products are manufactured in environments that control the level of viable and non-viable particulate and to establish that the control is taking place periodic monitoring must be performed. But any time monitoring occurs there is the potential that the results will exceed limits that have been established, What actions to be taken when this occurs should be appropriate and designed to determine the cause of the limit excursion. Knowing what is appropriate is important to ensure that the investigation is performed effectively.

This presentation will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions. It will also offer some guidance on how to establish or reestablish limits that are appropriate to the specific manufacturing process. There will also be discussion on how to document the results of the investigation.

Areas Covered in the seminar:

• What to investigate following an alert limit excursion in viable monitoring for surface or air.
• What to investigate following an action limit excursion in viable monitoring for surface or air.
• What actions to take based on the investigation results for viables.
• Evaluation of limits for viables for surface and air.
• What to investigate following an alert limit excursion in non-viable monitoring.
• What to investigate following an action limit excursion in non-viable monitoring.
• What actions to take based on the investigation results for non-viables.
• Documentation of the investigation and actions.

Who will benefit:

This webinar will provide valuable information to all companies that manufacture medical products in environments that are controlled and monitored for viable or non-viable contamination.

• QA personnel
• Manufacturing
• R&D