{"id":563,"date":"2023-04-25T12:49:45","date_gmt":"2023-04-25T10:49:45","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=563"},"modified":"2023-04-25T17:38:40","modified_gmt":"2023-04-25T15:38:40","slug":"medical-devices-moist-heat-sterilization-application-of-en-iso-17665-1st04","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/regulatory-quality-trainings\/medical-devices-moist-heat-sterilization-application-of-en-iso-17665-1st04\/","title":{"rendered":"ST04 – Medical Devices: Moist Heat Sterilization – Application of EN ISO 17665-1ST04"},"content":{"rendered":"\n
\n

REF. ST04 – INTRA \/ INTER<\/p>\n\n\n\n

PROCESSES<\/p>\n<\/div><\/div>\n\n\n\n

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

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

International regulations that govern market authorization for Medical Devices require process control, including notably for sterilization processes.<\/p>\n\n\n\n

By applying EN ISO 17665-1, control of the moist heat sterilization process for medical devices is ensured.<\/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 the principles for validation and control of the moist heat sterilization process<\/li>\n\n\n\n
  • Be able to release sterile batches<\/li>\n\n\n\n
  • Be able to draw up specifications with the providers involved<\/li>\n\n\n\n
  • Control the impact of changes on the products<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
    <\/div>\n\n\n\n
    \n

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

    Medical Device manufacturers\/subcontractors, and more particularly:\u00a0<\/p>\n\n\n\n

      \n
    • R&D<\/li>\n\n\n\n
    • Methods<\/li>\n\n\n\n
    • Production<\/li>\n\n\n\n
    • Quality Control – Release<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
      <\/div>\n\n\n\n
      \n

      PREREQUISITES<\/h2>\n\n\n\n
        \n
      • Process qualification concepts<\/li>\n\n\n\n
      • Some familiarity with microbiology may help better understand that principles relative to the control of sterilization processes<\/li>\n<\/ul>\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
        • Case studies<\/li>\n\n\n\n
        • Normative references<\/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. Sterilization processes – General aspects, process validation principles<\/li>\n\n\n\n
          2. A few definitions<\/li>\n\n\n\n
          3. Moist heat sterilization\n
              \n
            • Description of the equipment<\/li>\n\n\n\n
            • Process steps<\/li>\n\n\n\n
            • Control parameters<\/li>\n\n\n\n
            • Validation methodology<\/li>\n\n\n\n
            • Process maintenance – revalidation<\/li>\n\n\n\n
            • Change control<\/li>\n\n\n\n
            • Subcontracting – Specifications<\/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><\/p>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

                REF. ST04 – INTRA \/ INTER PROCESSES COURSE DESCRIPTION International regulations that govern market authorization for Medical Devices require process control, including notably for sterilization processes. By applying EN ISO 17665-1, control of the moist heat sterilization process for medical devices is ensured. OBJECTIVES TARGET TRAINEES Medical Device manufacturers\/subcontractors, and more particularly:\u00a0 PREREQUISITES TRAINING RESOURCES […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[20,13],"tags":[],"_links":{"self":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/563"}],"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=563"}],"version-history":[{"count":1,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/563\/revisions"}],"predecessor-version":[{"id":565,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/563\/revisions\/565"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=563"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=563"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=563"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}