Wendy Mach has over 24 years of medical device manufacturing 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 validation. 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 and packaging microbial aerosol challenge studies.
She is a participating member on the Technical Committee ISO/TC 198 Sterilization of Healthcare Products, the subcommittee chairperson for ASTM F02.15 Chemical / Safety Properties, and is a member of the Packaging and Distribution Expert Committee for United States Pharmacopeia (USP). Wendy’s participation on the domestic and international committees allows her to consult with clients to meet the regulatory standards of today – while preparing them to meet the standards of the future.
- Packaging Trends Leading to Increased 483's
- Tuesday, February 11 • 1:30 PM - 2:15 PM
- Medical Device Validation – Biocompatibility Testing, Cleaning, Sterilization and Packaging
- Wednesday, February 12 • 8:30 AM - 4:45 PM