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Packaging Trends Leading to Increased 483’s

This presentation will take a look at some of the recent Packaging trends that are outlined by increased 483 letters to medical device manufacturers.   Additionally an examination into how to prevent these common trends from occurring in your company will be discussed.

 

Wendy Mach

Wendy Mach

RM (NRCM), CQA (ASQ)
Packaging Expert

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...