{"id":1109,"date":"2023-03-23T05:47:48","date_gmt":"2023-03-23T11:47:48","guid":{"rendered":"https:\/\/smdlearning.com\/product\/process-change-assessment\/"},"modified":"2025-08-07T15:24:57","modified_gmt":"2025-08-07T21:24:57","slug":"process-change-assessment","status":"publish","type":"product","link":"https:\/\/smdlearning.com\/product\/process-change-assessment\/","title":{"rendered":"Process Change Assessment"},"content":{"rendered":"<p>Learn about the change control process, the interaction with different elements of the quality system, and the considerations when creating a process change assessment.<\/p>\n<p><span style=\"color: #004f71;\"><strong>Duration:<\/strong><\/span> 12 hours<\/p>\n<p><span style=\"color: #004f71;\"><strong>CEUs: <\/strong><\/span>1.3<\/p>\n<p><span style=\"color: #004f71;\"><strong>Modality:<\/strong><\/span>\u00a0Group<\/p>\n<p><span style=\"color: #004f71;\"><strong>Participant limit:<\/strong><\/span>\u00a015<\/p>\n<p><b><a href=\"https:\/\/smdacademy.smdlearning.com\/pluginfile.php\/155\/course\/summary\/Process_Change_Assessment.pdf?time=1695953690640\">Download Course Technical Information<\/a><\/b><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The objective of this course is to provide students with an understanding of the change control process, interaction with different elements of the quality system and considerations when creating a process change assessment in the medical devices industry.<\/p>\n<p id=\"yui_3_17_2_1_1695959226177_1370\">Throughout the course, students will engage in hands-on learning experiences, applying their knowledge of change control in the medical device industry, ensuring regulatory compliance, maintaining quality standards, and addressing real-world challenges.<\/p>\n<h4>At The End Of The Course You Will Be Able To<\/h4>\n<ul>\n<li>Understand the concepts of change control in the medical device industry.<\/li>\n<li>Understand an overview of the medical device change control and regulatory and quality management system (QMS) compliance.<\/li>\n<li>Understand the types of changes according to different criteria.<\/li>\n<li>Learn the elements of the impact assessment in medical device change control process.\n<ul>\n<li>Change Description<\/li>\n<li>Scope of Chance<\/li>\n<li>Risk Assessment<\/li>\n<li>Validation Assessment<\/li>\n<li>Production and Process Assessment<\/li>\n<li>Regulatory Assessment<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li>Experience in a practical way, real-world situations, and examples on change control.<\/li>\n<\/ul>\n<h4 class=\"subtitle\">Course Content<\/h4>\n<ol>\n<li class=\"subtitle\">Regulatory Requirements<\/li>\n<li class=\"subtitle\">Definition of Change<\/li>\n<li class=\"subtitle\">Change Workflow<\/li>\n<li class=\"subtitle\">Change Types<\/li>\n<li class=\"subtitle\">The Impact Assessment\n<ul>\n<li class=\"subtitle\">Change Description<\/li>\n<li class=\"subtitle\">Scope of Chance<\/li>\n<li class=\"subtitle\">Risk Assessment<\/li>\n<li class=\"subtitle\">Validation Assessment<\/li>\n<li class=\"subtitle\">Production and Process Assessment<\/li>\n<li class=\"subtitle\">Regulatory Assessment<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n","protected":false},"featured_media":756,"comment_status":"open","ping_status":"closed","template":"","meta":{"_acf_changed":false},"product_cat":[31],"product_tag":[],"class_list":{"0":"post-1109","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-processvalidationandsustaining","8":"first","9":"instock","10":"downloadable","11":"virtual","12":"taxable","13":"product-type-simple"},"acf":[],"_links":{"self":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1109","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/comments?post=1109"}],"version-history":[{"count":3,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1109\/revisions"}],"predecessor-version":[{"id":2473,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1109\/revisions\/2473"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/media\/756"}],"wp:attachment":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/media?parent=1109"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product_cat?post=1109"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product_tag?post=1109"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}