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Virtual Engineering Week Schedule Viewer

Virtual Engineering Week is bringing a full week of best-in-class education to the global design, engineering, and manufacturing communities. Join us each morning to hear from medical device industry professionals during the Medtech Mornings series, and in the afternoons to learn from engineering and manufacturing experts in areas like 3D printing, smart manufacturing, packaging, materials and sustainability, and career development.

All times listed below are PST (Pacific Standard Time).

Stability Testing in Today's New Regulatory Environment

Wendy Mach  (Senior Manager, Technical Consulting, Nelson Laboratories, LLC)

Date: Wednesday, December 2

Time: 10:30 am - 11:00 am

Track: MedTech Mornings: Medical Packaging

Vault Recording: TBD

This session will review how to demonstrate maintenance of a sterile barrier system over time. It will look at differences between real time aging and the use of accelerated aging, conditions tested, and how these need to be managed within the new MDR and ISO 11607 revision. Topics covered include:

• Setting up accelerated aging studies
• Real time versus accelerated aging studies
• Labeling and compliance to the new revisions
• Change management