Joyce M. Hansen
President, JM Hansen & Associates

Professional Experience

• In 2005, Joyce founded JM Hansen and Associates to build a practice which provides manufacturing companies with strategic plans for optimized use of internal sterilization equipment or the use of contract sterilization and laboratory services.  The strategic plans focus on validation of the appropriate sterilization process (radiation, ethylene oxide, moist heat, etc.) to meet regulatory requirements.  She specializes in the area of radiation (gamma, electron beam and x-ray) and ethylene oxide sterilization.  She has provided technical support for product and process problem solving, educational seminars, and resolution of U.S. and International regulatory compliance issues.
   
• Prior to becoming a consultant, Joyce spent 6 years (from 1998 to 2004) working for Baxter Healthcare Corporation, a world-wide leading supplier of healthcare products, systems and services as Vice President, Sterility Assurance and Sterilization Core Technical Competency (CTC) Champion.  In this position she was responsible for directing personnel that supported product development, sterilization technical support to worldwide operations, and sterilization research and development.
   
• Joyce was the Director, Global Sterility Assurance for Sherwood Davis & Geck (1997 to 1998) and was responsible for the sterilization operations worldwide (radiation, ethylene oxide, moist heat, contract sterilization) and sterility assurance laboratories worldwide (microbiology, chemistry and toxicology). 
   
• Previously, Joyce held the positions:
  • Director, Sterilization Science Center for Baxter Healthcare Corporation where she was responsible for the development of a new department that specialized in sterilization research and development;
  • Vice President, Regulatory Affairs/Quality Assurance for Isomedix (a contract firm offering gamma and ethylene oxide sterilization); and
  • several positions of increasing responsibility at Becton Dickenson & Company plant manufacturing, research and corporate faciltiies.

Professional Activities

Joyce is actively involved in industry activities, task forces and working groups.

• She is the convenor of the International Organization for Standardization (ISO), Technical Committee (TC) 198, Sterilization of healthcare products, Working Group 2 on Radiation Sterilization.  She is a member of the Joint Chairman’s Advisory Panel to harmonize sterilization standards between ISO/TC 198 and CEN/TC 204, and is a U.S. representative to ISO/TC 198, Working Group 8, Microbiological Methods.
   
• She is the co-Chair of the Association for the Advancement of Medical Instrumentation (AAMI) Microbiological Quality (Sterility Assurance Level) Working Group; past co-Chair of the AAMI Radiation Sterilization working group and past co-Chair of the AAMI Microbiological Methods working group.

Joyce holds a Bachelor of Science in Microbiology from South Dakota State University, and a Masters in Management from the Kellogg Executive Management Program at Northwestern University.  She received an award for Outstanding Contribution to Radiation Processing in 2001 at the International Meeting in Radiation Processing in Avignon, France.

Joyce is the author and co-author of over 12 articles and/or chapters in books on sterilization.  She has presented numerous lectures for training purposes and has been an invited speaker for domestic and international regulatory agencies, and industry organizations.