EO Sterilization: Validating & Managing the Process
Wednesday, March 22, 2017, 7:00 to 9:00 pm
to register - go to: ncdgmar2017.eventbrite.com
Stellartech Research Corporation
560 Cottonwood Drive
Milpitas, CA 95035
Topic: The March NCDG session will be approximately an hour presentation followed by a share session of “stories” or incidents with lessons learned that could be of immediate or longer term value to quality professionals responsible for EO sterilization of medical products. In addition, we would like each of you to bring at least a question or something to share about EO sterilization that you have experienced that would be of benefit to the group. After this, an open forum and networking session for quality professionals will be held.
Featured Speaker: Thomas Lypka
Thomas began working with EO sterilization in a “baptismal by fire,” “sink or swim” crisis in early 1976 when he was called upon to retro validate an EO sterilizer which had been operating out of control. The learning and subsequent retro-validation was acceptable and Thomas was then charged with building, staffing and operating a Sterilization & Engineering Development Lab which duplicated any sterilization process in the world including gas sterilization. Thomas was responsible for the design, fabrication and development, then operation of several EO sterilizers which at that time used a variety of ETO gas mixtures available to the industry. When Thomas relocated to California in 1981, he used his previous EO experience to guide medical device designers to develop devices that would be compatible with the EO sterilization process. Currently, Thomas is with D2EO, an EO sterilization contract provider located in San Jose, first as Director of RA/QA in 2014, and now as Director of Operations. Additionally, Thomas has several consulting assignments which include building and teaching the operating EO gas contract sterilization facilities.
Thomas earned his BScME degree at Michigan Tech University majoring in Internal Combustion Engines and Manufacturing and with minors in Metallurgy and Mathematics. Thomas earned his QA certification from D’Anza College where he additionally sponsored the QA Department’s off-site classes at Syntex in Palo Alto. Thomas also earned certifications from the University of Michigan graduate school of Management.
Moderator: George Marcel
Location: Stellartech Research Corporation, 560 Cottonwood Dr., Milpitas, CA 95035
Food: Snacks equivalent to a light meal and beverages are provided at each event at no additional cost.
Email: contact George Marcel (firstname.lastname@example.org).
Registration Link: ncdgmar2017.eventbrite.com
ONLY Check or Credit Card accepted at door
Questions: For information about this session, contact Gary Seeger (email@example.com)
Formal discussion and questions will end between 8:30 - 8:45 pm to allow time for networking after the roundtable presentation.
Materials: Handouts provided. Please limit distribution to immediate personal professional use only.
Remote Access: If you are unable to attend, you can still join us remotely via webinar link at no cost:
Note: Presentation Materials or RU credits not provided
Webinar link for March Roundtable