Speaker Profile

Gerry O'Dell

President, Gerry O’Dell Consulting

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, and compliance. Prior to starting Gerry O’Dell Consulting, she worked for Johnson & Johnson and has over twenty-five years of experience in the medical device industry. Gerry is a Registered Microbiologist with the National Registry of Microbiologists in the area of Consumer Products & Quality Assurance. Gerry is actively involved in the development of sterilization standards and is currently Co-Chair of the AAMI Industrial Ethylene Oxide Sterilization Working Group. She is also a member of several other working groups which are related to EO residuals, Radiation Sterilization, Sterility Assurance Levels, Reusable Devices, and Microbiological Methods.

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Sterilization Process for Product Developers - A Complete Guide

Product developers have the responsibility of the development of medical devices or healthcare products that will be sterilized; however they may not have an adequate understanding of the sterilization processes and its impact to the functionality of the product and its package.

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