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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

Packaging Validations: The Current and Future State of Testing

Published Date: July 26, 2019

This webinar will touch on some of the changes implemented with the release of the MDR’s in the European Union and the impact to the packaging requirements. Specifically these new regulations prompted the changes to the packaging industry resulting in the newly published ISO 11607. A discussion on 3 key points regarding packaging will be discussed and how the ISO 11607 directs device manufacturers to meet these changes. Additionally a brief discussion on the life cycle approach to packaging validations including an in-depth look at a couple specific tests and finally a high level look at sample size considerations as part of the establishing a validation testing plan.

By the end of this webinar you should know:

  1. MDR changes to the packaging process
  2. Overview of Common Packaging test methods
  3. Sample size considerations

Presenter: Wendy Mach, Consulting Manager, Nelson Labs, LLC

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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