Wendy Mach is a Senior Manager, Technical Consulting at Nelson Laboratories; a microbiological testing company specializing in improving the quality of life by ensuring medical products are safe, sterile, and functional. Wendy has over 26 years of medical device manufacturing, sterilization, packaging and laboratory experience. She worked in the medical manufacturing environment in Minnesota for seven years, performing ethylene oxide (EO) and gamma radiation sterilization validations. While at the manufacturing site, she also insourced the microbiology tests for sterility assurance and related equipment validations. Wendy also spent four years as a lab supervisor, managing the sterility, microbial limits, bioburden, endotoxin, antimicrobial effectiveness services. In 2004 Wendy moved to Salt Lake City to accept a position in the EO department at Nelson Laboratories and was responsible for sterilization D-value testing and packaging microbial aerosol challenge studies.
Wendy is the subject matter expert for ship testing, package strength, integrity and microbial barrier tests. As section leader, she was instrumental in Nelson Labs being selected by DuPont for their 10 year re-validation project for DuPont Tyvek® packaging for medical materials. In her current role Wendy oversees all consulting projects associated with Hospital Reprocessing and Sterilization, Packaging, and Microbiology. Wendy serves on industry committees and gives frequent presentations on best practices for packaging material selection and validation activities.
- Stability Testing in Today’s New Regulatory Environments
- Thursday, November 4 • 10:30 AM - 11:15 AM
- Packaging validation 101
- Thursday, November 4 • 1:30 PM - 2:30 PM