ComplianceOnline

Developing an ethylene oxide (EO) sterilization process for a product with limitations

Instructor: Gerry O Dell
Product ID: 701680
Training Level: Intermediate to Advanced
  • Duration: 80 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Sep-2010

Training CD / USB Drive

$500.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This EO sterilization training Webinar will discuss how to modify EO sterilization process for complicated medical products which are sensitive to moisture, temperature, vacuum changes.

Why Should You Attend:

Medical products have become more complicated with many containing computer chips, batteries, antibiotics, or other items/materials that make sterilization a significant challenge. These products that present difficult challenges to the EO sterilization process may include those products that have sensitivity to temperature, have moisture limitations, are sensitive to vacuum changes (either level or rate), retain EO, have batteries, or a combination of these factors. Developing a sterilization process presents a challenge but in virtually all cases a process can be developed that meets the requirement to have a sterile functional product.

This presentation will address the various modifications that can be made to the EO process to accomplish this goal and the impact of those modifications. We will discuss the methods to limit moisture exposure, Running a low temperature process, How to address vacuum sensitivity, How to reduce EO residuals.

Areas Covered in the Seminar:

  • How to limit moisture exposure.
  • Running a low temperature process.
  • How to address vacuum sensitivity.
  • Parameter inter-relationships.
  • How to reduce EO residuals.
  • Testing outside of the sterilization facility.
  • Considerations for validation and routine processing.

Who Will Benefit:

This webinar will provide valuable information to all companies that produce sterile products.

  • QA personnel
  • Validation specialists
  • Manufacturing personnel involved in validations
  • R&D specialists
  • Product Development Engineers

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.

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Refund Policy

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. ComplianceOnline 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.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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