On this episode of SPOT radio, Charlie Webb speaks with Wendy Mach with Nelson Labs about their upcoming Packaging Validation 101 Webinar. This online event will cover topics such as: determining the appropriate sample size for testing, writing the validation protocol, developing the test plan, selecting appropriate tests, family grouping and worst-case considerations, and creating the appropriate samples.
Wendy Mach is with Nelson labs, she has over 27 years of medical device manufacturing and laboratory experience. She is a known expert in the MedTech packaging industry, a sought-after speaker, and actively contributes to industry publications.
In her role as Consulting Manager, Wendy works with clients to address their unique needs in order to meet the requirements for packaging validations.
Wendy is a participating member of the Technical Committee ISO/TC 198 Sterilization of Healthcare Products, the subcommittee chairperson for ASTM F02.15 Chemical / Safety Properties, and is chairperson of the Packaging & Sterile Barrier Systems Working Group for the Society for Sterilization Assurance Professionals (SfSAP). 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 demands of the future."
Event link for more information and to register:
Phone: 1 (800) 826-2088