{"id":499,"date":"2023-04-25T10:29:38","date_gmt":"2023-04-25T08:29:38","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=499"},"modified":"2023-04-25T10:29:39","modified_gmt":"2023-04-25T08:29:39","slug":"mq10-validation-of-software-applications","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/regulatory-quality-trainings\/mq10-validation-of-software-applications\/","title":{"rendered":"MQ10 – Validation of Software Applications"},"content":{"rendered":"\n
\n

REF. MQ10 – INTRA \/ INTER<\/p>\n\n\n\n

QUALITY SYSTEM<\/p>\n<\/div><\/div>\n\n\n\n

<\/div>\n\n\n\n
\n

COURSE DESCRIPTION<\/h2>\n\n\n\n

This course will allow you to acquire practical knowledge to validate software applications in accordance with the requirements of ISO 13485:2016.<\/p>\n\n\n\n

N.B. This course does not cover the validation of software considered to constitute Medical Devices or of software incorporated into Medical Devices.<\/em><\/p>\n<\/div><\/div>\n\n\n\n

<\/div>\n\n\n\n
\n\t
\n\t\t

DURATION<\/h3>\n\t\t

1 day \/ 7 hours<\/p>\n\t<\/div>\n\t

\n\t\t\n\t\t

IN-PERSON<\/h3>\n\t<\/div>\n
\n\t\t\n\t\t

VIRTUAL CLASSROOM<\/h3>\n\t<\/div>\n<\/div>\n\n\n\n
\n

OBJECTIVES<\/h2>\n\n\n\n
    \n
  • Understand applicable normative requirements<\/li>\n\n\n\n
  • Understand the software application validation methodology<\/li>\n\n\n\n
  • Define and manage validation documents<\/li>\n\n\n\n
  • Apply the concepts learned to case studies<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
    <\/div>\n\n\n\n
    \n

    TARGET TRAINEES<\/h2>\n\n\n\n

    Manufacturers of Medical Devices and subcontractors<\/p>\n<\/div><\/div>\n\n\n\n

    <\/div>\n\n\n\n
    \n

    PREREQUISITES<\/h2>\n\n\n\n

    Familiarity with the requirements applicable to quality management systems (ISO 13485)<\/p>\n<\/div><\/div>\n\n\n\n

    <\/div>\n\n\n\n
    \n

    TRAINING RESOURCES<\/h2>\n\n\n\n
      \n
    • PowerPoint presentation handed out at the end of training<\/li>\n\n\n\n
    • Examples tailored to the company\u2019s products<\/li>\n\n\n\n
    • Group exercises<\/li>\n\n\n\n
    • Quizzes<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
      <\/div>\n\n\n\n
      \n

      COURSE CONTENT<\/h2>\n\n\n\n

      Participants welcomed and presented\/Course objectives\/Presentation of the course content<\/strong><\/p>\n\n\n\n

        \n
      1. Introduction<\/li>\n\n\n\n
      2. Regulatory, normative and industrial context<\/li>\n\n\n\n
      3. Software application validation principles\n
          \n
        • Key principles<\/li>\n\n\n\n
        • Lifecycle approach<\/li>\n\n\n\n
        • Risk management<\/li>\n<\/ul>\n<\/li>\n\n\n\n
        • Software application validation activities\n
            \n
          • General information<\/li>\n\n\n\n
          • Validation process<\/li>\n\n\n\n
          • Documentation<\/li>\n<\/ul>\n<\/li>\n\n\n\n
          • Validation of a software application – implementation\n
              \n
            • Validation plan, risk management<\/li>\n\n\n\n
            • Documentation<\/li>\n<\/ul>\n<\/li>\n\n\n\n
            • Summary\/Q&A<\/li>\n\n\n\n
            • Course evaluation and conclusion<\/li>\n<\/ol>\n<\/div><\/div>\n\n\n\n
              <\/div>\n\n\n\n
              \n

              EVALUATION METHODS<\/h2>\n\n\n\n
                \n
              • Course evaluation quiz<\/li>\n\n\n\n
              • Satisfaction survey<\/li>\n\n\n\n
              • Attendance certificate<\/li>\n<\/ul>\n\n\n\n

                This training is assessed based on an evaluation of each individual\u2019s acquisition of knowledge via quizzes during and at the end of the program (success criteria >= 75%).<\/em><\/em><\/p>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

                REF. MQ10 – INTRA \/ INTER QUALITY SYSTEM COURSE DESCRIPTION This course will allow you to acquire practical knowledge to validate software applications in accordance with the requirements of ISO 13485:2016. N.B. This course does not cover the validation of software considered to constitute Medical Devices or of software incorporated into Medical Devices. OBJECTIVES TARGET […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[17,13],"tags":[],"_links":{"self":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/499"}],"collection":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/comments?post=499"}],"version-history":[{"count":1,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/499\/revisions"}],"predecessor-version":[{"id":501,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/499\/revisions\/501"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=499"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=499"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=499"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}