{"id":567,"date":"2023-04-25T12:52:13","date_gmt":"2023-04-25T10:52:13","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=567"},"modified":"2023-04-25T17:38:28","modified_gmt":"2023-04-25T15:38:28","slug":"medical-devices-dry-heat-sterilization-application-of-en-iso-20857","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/regulatory-quality-trainings\/medical-devices-dry-heat-sterilization-application-of-en-iso-20857\/","title":{"rendered":"ST05 – Medical Devices: Dry Heat Sterilization – Application of EN ISO 20857"},"content":{"rendered":"\n
\n

REF. ST05 – 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 20857, control of the dry 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 dry 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. Sterilization by dry heat\n
              \n
            1. Description of the equipment<\/li>\n\n\n\n
            2. Process steps<\/li>\n\n\n\n
            3. Control parameters<\/li>\n\n\n\n
            4. Validation methodology<\/li>\n\n\n\n
            5. Process maintenance – revalidation<\/li>\n\n\n\n
            6. Change control<\/li>\n\n\n\n
            7. Subcontracting – Specifications<\/li>\n<\/ol>\n<\/li>\n\n\n\n
            8. Summary\/Q&A<\/li>\n\n\n\n
            9. 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. ST05 – 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 20857, control of the dry 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\/567"}],"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=567"}],"version-history":[{"count":1,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/567\/revisions"}],"predecessor-version":[{"id":568,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/567\/revisions\/568"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=567"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=567"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=567"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}