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EO Sterilization Equipment, Software and Product Validation Per ISO 11135
Date :
Place : United States, Palo Alto
Contact Person:Ashutos Swain
Description:
Medical device sterilization failures can have serious consequences to patient health and a company’s reputation with both regulatory agencies and the public. EO sterilization is one of the most common methods of device sterilization, and must be performed by a company on its products whether the company does in-house sterilization or contracts a third party to perform it. A review of Internet forums shows confusion as to what is involved in V&V in general and EO sterilization in particular. And what must be addressed to ensure all requirements of sterilization validation are addressed per the ISO 11135 standard. What are the "must have" elements? How are the many different required test cases constructed, formatted, and completed? How are all these unique elements integrated into the final EO sterilization validation documentation? How is the often neglected EO sterilization chamber control software / firmware V&V activities performed and documented with minimal extra activities. This webinar will use ISO 11135’s requirements to address such point as: BI characterization, B&F testing, Bioburden, product characterization, PCDs, SAL, EO IQ, OQ, MPQ, and PPQ (terms / acronyms will be explained) . It will focus on the overkill approach, test case constructions, required software documentation, and re-qualification. The methods discussed provide a field-tested approach to EO sterilization validation and its documentation, including the chamber control software. The models presented simplify product, process, equipment, software V&V, assuring key US FDA and ISO 11135 requirements are not overlooked. 21 CFR Part 11 is also briefly considered.EO Sterilization Equipment, Software and Product Validation Per ISO 11135 will be held in Palo Alto,United States on date 2020-11-18
Deadline for abstracts/proposals : 8th November 2020
Organized By :Complianceonline
Keynote Speakers :
Check the event website for more details.
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