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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.

Description

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

Areas Covered

•    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
•     R&D
•     Engineering
•     Software engineers
•     Manufacturing / Operations
•     Sterilization personnel
•     Marketing
•     Purchasing
•     Consultants
•     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. 

Speaker Profile

John E Lincoln

Principal, J. E. Lincoln and Associates LLC

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, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS / CGMP audits and problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).

In addition, he has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He is a graduate of UCLA.

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