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2020 - EO Sterilization Equipment, Software and Product Validation Per ISO 11135
Date2020-11-18
Deadline2020-11-08
VenueOnline event, USA - United States 
KeywordsEthylene Oxide; EO; EtO
Topics/Call fo Papers
ISO 11135:2014 – current requirements
Overkill approach
BI, PCD, SAL, B&B, Bioburden terms explained
Product characterization considerations / documentation
How to use the IQ, OQ, MPQ, and PPQ as required under ISO 11135
Constructing the several different test case categories and populating them during validation
Required preliminary verification activities – choices under ISO 11135
The 11 Elements of the FDA’s software / firmware VT&V "Model".
Some Part 11 software V&V consideration.
Overkill approach
BI, PCD, SAL, B&B, Bioburden terms explained
Product characterization considerations / documentation
How to use the IQ, OQ, MPQ, and PPQ as required under ISO 11135
Constructing the several different test case categories and populating them during validation
Required preliminary verification activities – choices under ISO 11135
The 11 Elements of the FDA’s software / firmware VT&V "Model".
Some Part 11 software V&V consideration.
Other CFPs
Last modified: 2020-10-05 16:40:20