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

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.

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

Instructor Profile:
Gerry O’Dell, is President of Gerry O’Dell Consulting, a consulting firm based in the United States with clients around the world. Gerry O’Dell consults to medical device and pharmaceutical companies related to all the major sterilization methodologies, microbiology, environmental control, laboratory compliance, failure investigation, etc. Her varied background includes extensive knowledge in sterilization technology, laboratory management, microbiological testing (including pyrogens), decontamination of returned goods, and compliance.

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-five years of experience in the medical device industry.

Gerry is a member of the Association for the Advancement of Medical Instrumentation (AAMI) and actively participates in the Sterilization Standards Committee activities. She is currently Co-Chair of the AAMI Industrial Ethylene Oxide Sterilization Working Group and a member of the U.S. Sub-TAG for ISO/TC 198/WG 1. She is also a member of the Sterilization Residuals, Radiation Sterilization, Sterility Assurance Level (SAL), Compatibility of Materials Subject to Sterilization, and Microbiological Methods Working Groups; actively participating in the development of several standards and guidance documents. Gerry is a Registered Microbiologist with the National Registry of Microbiologists in the area of Consumer Products & Quality Assurance. She is also a member of the American Society for Microbiology (ASM), American Society for Testing & Materials (ASTM), and PDA.