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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

Focus on Fundamentals: Packaging

Published Date: September 7, 2022

With no relief in sight for supply chain issues and sterilization constraints, understanding the options associated with change has become an immediate need in industry.  This 3-day webinar will identify considerations and challenges outlined in regulatory standards to allow for success in an agile environment.  Our topics of focus include navigating Ethylene Oxide & Radiation Sterilization, Packaging, and Biocompatibility/Biosafety changes and addressing the expectations around managing changes.

Day 2: Packaging: Evaluating the Impact of a Change

Abstract: Supply chain disruptions have necessitated a shift in supply chain management.  While adding diversity and redundancy into your supply chain makes sense from a business perspective, any changes to packaging, devices or sterilization require thoughtful consideration as to impact.  This presentation uses case study examples to demonstrate how to tackle common changes through a packaging lens.

  • How to handle changes to the sterile barrier system or protective packaging
  • How do device changes impact packaging?
  • How changing sterilization can affect packaging
Jennifer Gygi

Jennifer Gygi

BS, SM (NRCM)
Packaging Expert

Jennifer Gygi is an Expert Technical Consultant at Nelson Laboratories; a microbiological testing company specializing in improving the quality of life by ensuring medical products are safe, sterile, and functional. Jennifer has over 26 years of laboratory experience at Nelson Labs. She has worked in the Microbiology, Bioburden, Organism IDs, Packaging and QC Validations groups....

Wendy Mach

Wendy Mach

BS, RM (NRCM), CQA (ASQ)
Senior Manager, Expert Advisory Services

Wendy Mach has over 27 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...

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