Why Should You Attend:
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.
Areas Covered in the Webinar:
Who Will Benefit:
From industries primarily including Medical Devices, Combination ProductsInstructor Profile:
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 37 years’ experience in U.S. FDA-regulated industries, 23 as an independent consultant. John has worked with companies from start-up to Fortune 100, worldwide. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, submissions, process / product / equipment including QMS and software validations, ISO 14971 product risk management and human factors files / reports, Design History Files, Technical documentation. He's held positions in Engineering, QA, QAE, RA, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, written numerous chapters for books on validation, conducted workshops and webinars worldwide. John is a graduate of UCLA.
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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