{"id":1102,"date":"2023-03-23T05:47:48","date_gmt":"2023-03-23T11:47:48","guid":{"rendered":"https:\/\/smdlearning.com\/product\/21-cfr-part-820-fda-quality-system-regulation\/"},"modified":"2025-08-07T15:14:22","modified_gmt":"2025-08-07T21:14:22","slug":"21-cfr-part-820-fda-quality-system-regulation","status":"publish","type":"product","link":"https:\/\/smdlearning.com\/product\/21-cfr-part-820-fda-quality-system-regulation\/","title":{"rendered":"21 CFR Part 820 \u2013 FDA Quality System Regulation"},"content":{"rendered":"

Learn about of the Code of Federal Regulations Title 21, Part 820, Understanding FDA Quality System Regulation and process to develop, manufacture and control a medical device product.<\/p>\n

Duration:<\/strong><\/span>\u00a04 hours<\/p>\n

CEUs:<\/strong><\/span> 0.5 hours<\/p>\n

Modality:<\/span>\u00a0<\/strong>Group<\/p>\n

Participant limit:<\/strong><\/span>\u00a015<\/p>\n

Download Course Technical Information<\/a><\/b><\/p>\n","protected":false},"excerpt":{"rendered":"

The objective of this course is to provide the students with top to bottom understanding of the 21 CRF 820 regulation and the interpretation clause -by clause of this regulation for a medical device manufacturer.<\/p>\n

Throughout the course, students will engage in hands-on learning experiences, applying their knowledge of FDA Quality System Regulation requirements to tackle real-world case scenarios typical of the medical device industry.<\/p>\n

At The End Of The Course You Will Be Able To<\/h4>\n
    \n
  • Understand the importance, purpose, and the framework of general requirements for the design and manufacture of medical devices per FDA 21 CFR Part 820 regulation (QSR).<\/li>\n
  • Key factors to comply and maintain compliance to the QSR.<\/li>\n
  • Understand how the company\u2019s quality management system fulfils and is connected to the FDA QSR.<\/li>\n
  • Learn the general requirements from all Sub-parts of 21 CFR Part 820 and how they correlate to the company quality system to support day-to-day activities.<\/li>\n
  • \u00a0Experience and apply FDA QSR requirements to solve in class real case situations that could be faced by a professional in this industry and to maintain compliance according to the standards.<\/li>\n<\/ul>\n

    Course Content<\/h4>\n
      \n
    1. Overview<\/li>\n
    2. Subpart B\u2014Quality System Requirements<\/li>\n
    3. Subpart C\u2014Design Controls<\/li>\n
    4. Subpart D\u2014Document Controls<\/li>\n
    5. Subpart E\u2014Purchasing Controls<\/li>\n
    6. Subpart F\u2014Identification and Traceability<\/li>\n
    7. Subpart G\u2014Production and Process Controls<\/li>\n
    8. Subpart H\u2014Acceptance Activities<\/li>\n
    9. Subpart I\u2014Nonconforming Product<\/li>\n
    10. Subpart J\u2014Corrective and Preventive Action<\/li>\n
    11. Subpart K\u2014Labeling and Packaging Control<\/li>\n
    12. Subpart L\u2014Handling, Storage, Distribution, and Installation<\/li>\n
    13. Subpart M\u2014Records<\/li>\n
    14. Subpart N\u2014Servicing<\/li>\n
    15. Subpart O\u2014Statistical Techniques<\/li>\n<\/ol>\n","protected":false},"featured_media":771,"comment_status":"open","ping_status":"closed","template":"","meta":{"_acf_changed":false},"product_cat":[25],"product_tag":[],"class_list":{"0":"post-1102","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-fundamentalsforthemedicaldevicesindustry","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\/1102","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=1102"}],"version-history":[{"count":6,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1102\/revisions"}],"predecessor-version":[{"id":2455,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1102\/revisions\/2455"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/media\/771"}],"wp:attachment":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/media?parent=1102"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product_cat?post=1102"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product_tag?post=1102"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}