Changes to Ethylene Oxide sterilization in the new ISO 11135:2014
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Instructor Profile
Mark Roberts is the head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance. He was previously the Manager for the Western US for TĂœV SĂœD Product Service. He is an accredited lead auditor and notified body auditor.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Description The course will discuss all aspects of EO validations including cycle development, D-value determinations, bio burden resistance studies, biological indicator sterility testing, BI incubation reduction studies, comparative resistance testing, PCD development, temperature and humidity distribution studies, and sterilant residues. In addition, appropriate ways to sterilize small batches of clinical product will be addressed.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Why Should Attend This Webinar designed for acquaint those with ethylene oxide sterilization and the requirements needed to successfully validate the process. In addition, the new revision of ISO 11135 will be discussed as well as issues related to US FDA inspections and common citations regarding sterilization.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Objectives
A very good understanding of how ethylene oxide is used as a sterility, sterilization basics, and general microbiology as it relates to medical devices. Available techniques to develop and test sterilization cycles based on product resistance. A clear understanding of what is involved in validating an ethylene oxide cycle compliant with ISO 11135. An up-to-date perspective on standards development and what changes have taken place with the recent publication of ISO 11135-1:2007, ISO 11135-2:2008, and the revision to ISO 10993-7.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit
Medical Device and IVD Manufacturers RA/QA Microbiology Sterilization Specialist
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
How this Webinar works Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf format will be mailed to you Login to the session using the username and password provided to you Get answer to your queries through interactive Q&A sessions via chat
Track this link : Ethylene Oxide Sterilization
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Connect with Us Online Compliance Panel
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com