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.
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.Areas Covered in the Webinar:
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.
President, Gerry O’Dell Consulting
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.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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