{"id":1117,"date":"2023-03-23T05:47:48","date_gmt":"2023-03-23T11:47:48","guid":{"rendered":"https:\/\/smdlearning.com\/product\/medical-devices-capa\/"},"modified":"2025-08-07T15:34:33","modified_gmt":"2025-08-07T21:34:33","slug":"medical-devices-capa","status":"publish","type":"product","link":"https:\/\/smdlearning.com\/product\/medical-devices-capa\/","title":{"rendered":"Medical Devices CAPA"},"content":{"rendered":"<p>Learn the tools and practical experience to correctly define problems, identify root causes and implement solutions.<\/p>\n<p><span style=\"color: #004f71;\"><strong>Duration:<\/strong><\/span>\u00a012 hours<\/p>\n<p><span style=\"color: #004f71;\"><strong>CEUs: <\/strong><\/span>1.3<\/p>\n<p><span style=\"color: #004f71;\"><strong>Modality:<\/strong>\u00a0<\/span>Group<\/p>\n<p><span style=\"color: #004f71;\"><strong>Participant limit:<\/strong>\u00a0<\/span>15<\/p>\n<p><b><a href=\"https:\/\/smdacademy.smdlearning.com\/pluginfile.php\/223\/course\/summary\/Medical_Devices_CAPA.pdf?time=1707423794295\" target=\"_blank\" rel=\"noopener\">Download Course Technical Information<\/a><\/b><\/p>\n","protected":false},"excerpt":{"rendered":"<p>This course is intended to provide students with the elements of a corrective and preventive action (CAPA) system, taken to eliminate causes of non-conformities or other undesirable situations.<\/p>\n<p><span lang=\"en-us\" xml:lang=\"en-us\">This course is broken down into three modules. The first module identifies the primary elements and sequence of activities for conducting a CAPA. The second module explains how to define a problem statement and conduct the root cause investigations, tools that can help you in effectively investigating problems. The third module explains how to implement and effectively close out a CAPA.<\/span><b><\/b><\/p>\n<h4>At The End Of The Course You Will Be Able To<\/h4>\n<ul>\n<li>Understand FDA\u2019s and other regulatory officials\u2019 expectations for \u201cwhat CAPA is\u201d and the steps required to get you there.<\/li>\n<li>Know how to improve your CAPA process, from CAPA sources and preventive actions through root cause analysis, action plans and effectiveness check.<\/li>\n<li>Understand the main elements and sequence of activities for conducting a CAPA.<\/li>\n<li>Understand how to define a problem statement, the conducting of root cause investigations, tools that can aid you in effectively investigating problems.<\/li>\n<li>Recognize how to close the CAPA loop and the requirements to close CAPAs in a timely and complete manner.<\/li>\n<li>\u00a0Understand how to establish a compliant Corrective Action and Preventive Action (CAPA).<\/li>\n<\/ul>\n<h4 class=\"subtitle\">Course Content<\/h4>\n<ol>\n<li class=\"subtitle\">\u00a0Module 1. Initiate \u2013 Investigation Plan \u2013 Correction\/Containment\n<ul>\n<li class=\"subtitle\">Introduction to CAPA<\/li>\n<li class=\"subtitle\">Initiation<\/li>\n<li class=\"subtitle\">Investigation<\/li>\n<li class=\"subtitle\">Plan<\/li>\n<li class=\"subtitle\">Containment \/ Correction<\/li>\n<\/ul>\n<\/li>\n<li class=\"subtitle\">Module 2. Investigation, Root Cause Analysis \u2013 Solution V&amp;V\n<ul>\n<li class=\"subtitle\">Root Cause Analysis<\/li>\n<li class=\"subtitle\">Solution V&amp;&amp;<\/li>\n<\/ul>\n<\/li>\n<li class=\"subtitle\">Module 3. Implementation-VoE-Closure\n<ul>\n<li class=\"subtitle\">Implementation<\/li>\n<li class=\"subtitle\">VoE<\/li>\n<li class=\"subtitle\">Closure<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n","protected":false},"featured_media":717,"comment_status":"open","ping_status":"closed","template":"","meta":{"_acf_changed":false},"product_cat":[32],"product_tag":[],"class_list":{"0":"post-1117","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-qualityandcomplianceformedicaldevicesindustry","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\/1117","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=1117"}],"version-history":[{"count":4,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1117\/revisions"}],"predecessor-version":[{"id":2485,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1117\/revisions\/2485"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/media\/717"}],"wp:attachment":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/media?parent=1117"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product_cat?post=1117"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product_tag?post=1117"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}