Gerry O'Dell, Co-owner and Technical Director at O'Dell & Hodge Consulting, LLC, brings over four decades of specialized experience in microbiology and sterilization practices within the healthcare sector. As an ACI Certified Industrial Sterilization Specialist (CISS), Gerry has honed her expertise in various sterilization methods,...
Gerry O'Dell, Co-owner and Technical Director at O'Dell & Hodge Consulting, LLC, brings over four decades of specialized experience in microbiology and sterilization practices within the healthcare sector. As an ACI Certified Industrial Sterilization Specialist (CISS), Gerry has honed her expertise in various sterilization methods, including ethylene oxide (EO), moist heat (MH), and radiation (RAD). Her academic foundation, with a Master’s degree in Microbiology, complements her extensive practical knowledge, making her a sought-after consultant for medical device, biologics, and pharmaceutical companies.
At O'Dell & Hodge Consulting, Gerry collaborates closely with her partner, Samantha Hodge, to deliver comprehensive consulting services that encompass all aspects of sterilization and microbiology. Their work often involves conducting thorough supplier audits and enhancing quality systems to ensure compliance with stringent industry standards, including ISO and FDA regulations. Gerry's proficiency in quality management and auditing, particularly in relation to 21 CFR Part 11, positions her as a key resource for organizations striving to meet regulatory requirements and improve their operational efficiencies.
Key projects under Gerry’s leadership have included the development and implementation of robust quality systems tailored to the unique needs of clients in the healthcare industry. Her commitment to excellence and her ability to navigate complex regulatory landscapes have not only helped clients achieve compliance but have also fostered a culture of continuous improvement in sterilization practices. Gerry’s insights into industry best practices and her dedication to advancing sterilization technologies make her an invaluable asset to O'Dell & Hodge Consulting and the broader healthcare community.