Sterilization of Medical Devices Training Course (June 1 |
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Sterilization of Medical Devices Training Course (June 1
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Dublin, April 03, 2023 (GLOBE NEWSWIRE) -- The "Sterilization of Medical Devices Training Course" conference has been added to ResearchAndMarkets.com's offering. Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. These requirements have been supported by a portfolio of standards on: Designating products as sterile;Validating and routinely controlling the sterilization process; andMaintaining sterility over time with appropriate sterile barrier systems.This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them. This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies. Benefits in attending: Gain a comprehensive overview of medical device sterilizationRecognise the principles of the commonly applied methods of sterilizationLearn the regulatory requirements for sterilization and how to complyUnderstand the portfolio of supporting standards and their interrelationshipsRegistration details: 2 days live online trainingBrowser-based, no download usually requiredSee presenters and interact with fellow attendeesDownload documentation and certification of completionWho Should Attend: Microbiologists and sterilization professionalsQuality Management System (QMS) specialistsRegulatory Compliance specialistsInternal AuditorsRegulatory and Quality professionalsKey Topics Covered: Day 1 Introduction and welcomeThe use of standards and overview of standards for sterilization Role of standardsInteraction of standards and regulations for medical devicesPortfolio of sterilization standards General requirements ISO 14937 - Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devicesStructure of sterilization standardsCommon features of validation and routine control Microbiology quality Introduction to microbiologySources of microbial contaminationContamination control Microbiology methods Bioburden estimation - EN ISO 11737-1 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on productsTest of sterility - EN ISO 11737-2 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process Microbial inactivation Inactivation kineticsSterility assuranceEN 556-1 Sterilization of medical devices - Requirements for a terminally-sterilized device to be labelled "Sterile" Sterilization by irradiation Nature of ionizing radiationSources of ionizing radiationMeasurement of radiation doseInstallation Qualification, Operational Qualification and Performance QualificationEN ISO 11137-1 1 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesEN ISO 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine controlEN ISO 11137-4 Sterilization of health care products - Radiation - Part 4: Guidance on process control Q & ADay 2 Introduction and recap of day oneSterilization by irradiation (cont.) Establishing the sterilization doseEN ISO 11137-2 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization doseISO/TS 13004 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD Biological indicators EN ISO 11138 series - Sterilization of health care products - Biological indicators Syndicate exercise - Radiation sterilization Feedback and discussion Ethylene oxide sterilization EN ISO 11135 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices Ethylene oxide sterilizaton (cont.) EN ISO 11135 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices Syndicate exercise - Ethylene oxide sterilization Feedback and discussion Moist heat sterilization EN ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices Wrap up and Q & ASpeakers: Eamonn Hoxey Technical Author, Trainer and Consultant in Life Science E V Hoxey Ltd Eamonn Hoxey, is a technical author, trainer and consultant in life science areas including regulatory compliance, quality management, sterility assurance and standards development. Eamonn worked for Johnson & Johnson for 17 years in positions of increasing responsibility for Quality and Regulatory including Vice President of Compliance for J&J's medical devices companies. Prior to joining J&J, Eamonn spent 16 years with the UK Medical Devices Agency, including six years as Head of Device Technology and Safety. Eamonn is past chair of ISO TC 210 'Quality management and related general aspects for medical devices' and ISO TC 198, 'Sterilization of Healthcare products'. He is past chair of the Board of Directors of AAMI. Dr Hoxey graduated as a Bachelor of Pharmacy and has a Ph.D. in Pharmaceutical Microbiology from the University of Bath. He was designated a Fellow of the Royal Pharmaceutical Society of Great Britain in 2004. He received the BSI Wolfe-Barry medal in 2016 for his contribution to standards development. For more information about this conference visit https://www.researchandmarkets.com/r/gx2zaz About ResearchAndMarkets.comResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. 
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