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.
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. The action 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 re-establish limits that are appropriate to the specific manufacturing process. There will also be discussions on how to document the results of the investigation.
This OOS investigation training 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.
Gerry O’Dell, is owner and President of Gerry O’Dell Consulting, a consulting firm based in the United States with medical device and pharmaceutical clients around the world. Prior to starting Gerry O’Dell Consulting, she worked for Johnson & Johnson Medical, Inc. as the Manager of Laboratory & Sterilization Services which managed the sterilization program for J&J Medical in addition to providing laboratory testing services to several J&J companies. Before becoming a part of Johnson & Johnson Medical, Gerry was Manager of Sterilization Services at Critikon, Inc where she started as a Lab Technician. She holds both a Bachelor and Master of Science degree in Microbiology from the University of South Florida and has over twenty-nine years of experience in the medical device industry.
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