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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

Packaging Trends Leading to Increased 483’s

Published Date: July 10, 2020

This presentation will take a look at some of the recent Packaging trends that are outlined by increased 483 letters to medical device manufacturers.  Using data from the FDA website I will highlight cited issues with packaging manufacturing including issues with design, processing and validation testing.  Additionally, an examination into how to prevent these common trends from occurring within your company by following validated standard test methods specifically called out in the reviewed data.

You will learn:

  • Common errors that are occurring in the packaging manufacturing process
  • Issues cited by the FDA as not meeting the regulations
  • Sterile barrier validation failures
  • Review of packaging test methods to address common failures cited.
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...

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