{"id":4587,"date":"2023-06-12T21:55:01","date_gmt":"2023-06-12T21:55:01","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?post_type=regulator-sessions&p=4587"},"modified":"2023-06-12T22:59:00","modified_gmt":"2023-06-12T22:59:00","slug":"stability-medical-devices-webinar","status":"publish","type":"regulator-sessions","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/stability-medical-devices-webinar\/","title":{"rendered":"Stability \u2013 Medical Devices Webinar"},"content":{"rendered":"\n

The Medical Device Regulatory Convergence Project, co-led by USAID, ANSI, and AdvaMed through the Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector, in collaboration with the U.S. Food and Drug Administration (FDA), hosted a webinar on June 1 to present \u201cFundamentals of establishing sterile barrier systems for medical devices: package stability (shelf life) and package performance\u201d<\/strong> the \u201cConsiderations for assessing use-life of reusable devices\u201d<\/strong>, presented by Steven Turtil and the \u201cAssessing device performance for the labelled shelf-life\u201d, presented by Limin Sun.<\/p>\n\n\n\n

The agenda, presentations and recorded session are available below.<\/p>\n\n\n\n

Agenda<\/h2>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n

Recordings<\/h2>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n\n\n\n
Portuguese<\/a><\/div>\n<\/div>\n\n\n\n

Presentations<\/h2>\n\n\n\n

MEDICAL DEVICE STABILITY – Conducting Package Stability and Performance Validation for Terminally Sterilized Single-Use Medical Devices \u2014 and \u2014 Establishing Use-Life for Reusable Medical Devices – Steven Turtil , US FDA<\/strong><\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n\n\n\n
Assessing device performance for the labelled shelf-life – Limin Sun, US FDA<\/strong><\/h5>\n\n\n\n
\n
English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n<\/div>\n","protected":false},"parent":0,"template":"","event_category":[],"class_list":["post-4587","regulator-sessions","type-regulator-sessions","status-publish","hentry","description-off"],"acf":[],"yoast_head":"\nStability \u2013 Medical Devices Webinar - Regulatory Convergence<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/stability-medical-devices-webinar\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Stability \u2013 Medical Devices Webinar - Regulatory Convergence\" \/>\n<meta property=\"og:description\" content=\"The Medical Device Regulatory Convergence Project, co-led by USAID, ANSI, and AdvaMed through the Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector, in collaboration with the U.S. Food and Drug Administration (FDA), hosted a webinar on June 1 to present \u201cFundamentals of establishing sterile barrier systems for medical devices: package stability (shelf life)…\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/stability-medical-devices-webinar\/\" \/>\n<meta property=\"og:site_name\" content=\"Regulatory Convergence\" \/>\n<meta property=\"article:modified_time\" content=\"2023-06-12T22:59:00+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/training-and-capacity-building-resources\\\/regulator-sessions\\\/stability-medical-devices-webinar\\\/\",\"url\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/training-and-capacity-building-resources\\\/regulator-sessions\\\/stability-medical-devices-webinar\\\/\",\"name\":\"Stability \u2013 Medical Devices Webinar - 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