Live Webinar EO Sterilization Validation / Revalidation per ISO 11135
01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes
Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar
"Listen From John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries"
A brief discussion of the lethal rate BI / bioburden approach, and a more detailed discussion of the more commonly used Overkill approach descriptions, IQ, OQ, PQ - MPQ / PPQ.
This webinar will outline the required elements of a successful ethylene oxide (EO) sterilization validation process for medical devices as required by ISO 11135:2014. Hardware / chamber and software considerations and required documentation. Temperature and humidity mapping, BIs / PCDs and their placement. Basic system. A brief discussion of the lethal rate BI / bioburden approach, and a more detailed discussion of the more commonly used Overkill approach descriptions, IQ, OQ, PQ - MPQ / PPQ.
Why should you attend
Basic information of the EO sterilization process for successful medical device sterilization to meet ISO 11135 / U.S. FDA and EU MDR requirements. Discussion of the purpose and methodology for the various partial and full cycles, IQ, OQ, PQs, acceptance criteria, and a suggested report format. Useful whether a company will do the validation, contract for it, hire a consultant to assist, or review existing sterilization documentation of a vendo
• Key parts of ISO 11135:2014, and its implementation
• Control software description and suggested documentation (11 elements)
• Temperature and humidity mapping
• BI and PCD number and placement considerations
• Contract Lab Resources, B&F, BIs, residuals, sterility testing
• Fractional, Half-Cycle and Full Cycle runs
• IQ, OQ, PQs (MPQs and PPQs) test cases
• Pre- and Post (Aeration)- Conditioning
• Putting it all together – the Sterilization V&V Test Report.
• Revalidation frequency, considerations, and alternatives.
Who will Benefit
• Senior management
• QA / QAE / RA
• Software engineers
• Manufacturing / Operations
• Sterilization personnel
• All others tasked with product development, and sterilization / product sterility.
Industries who can attend
This 90-minute online course is intended for professionals in the Medical Device Industry.