{"id":1155,"date":"2018-06-19T22:20:08","date_gmt":"2018-06-20T04:20:08","guid":{"rendered":"https:\/\/www.designcontrolconsultant.com\/?page_id=1155"},"modified":"2019-01-23T19:57:01","modified_gmt":"2019-01-24T02:57:01","slug":"about-copy-copy-3","status":"publish","type":"page","link":"https:\/\/www.designcontrolconsultant.com\/?page_id=1155","title":{"rendered":"Design Controls & Risk Management Combined Course"},"content":{"rendered":"\n\t

Design Controls & Risk Management:\u00a0<\/strong>An Integrated Product Development Approach <\/em><\/h3>\n

\u00a0<\/strong>\u00a0 \u00a0<\/strong><\/p>\n

Day One<\/strong><\/p>\n

\u00a0<\/strong>1) Introduction <\/strong><\/p>\n

    \n
  • Instructor and Class\u00a0Introductions<\/li>\n
  • Course Objectives & Expectations<\/li>\n
  • Review Participant Objectives<\/li>\n<\/ul>\n

     <\/p>\n

    2)\u00a0Overview of Design Controls\u00a0<\/strong><\/p>\n

      \n
    • What is Design Control? (Concepts Defined)<\/li>\n
    • Why is Design Control important?<\/li>\n
    • FDA\u2019s Cradle to Grave Vision of the Total Product Life Cycle<\/li>\n
    • The \u201cUnwritten Laws\u201d of Design Control (Planning, Documentation, Risk Based Approach, Interactions)<\/li>\n<\/ul>\n

      \u00a0 \u00a0\u00a0<\/p>\n

      3)\u00a0Phase 0 (Research)<\/strong><\/p>\n

        \n
      • Timing of Design Control Elements During Product Development<\/li>\n
      • When Does Design Controls Start? When Does It End?<\/li>\n
      • Concept & Feasibility<\/li>\n
      • Development phases overview (phase 0-V)<\/li>\n<\/ul>\n

        \u00a0<\/strong>\u00a0<\/strong><\/p>\n

        4) Phase I (Requirements & Planning)<\/strong><\/p>\n

          \n
        • \u00a0<\/strong>Design and Development Planning<\/strong><\/li>\n
        • \n
            \n
          • Why does FDA require planning?<\/li>\n
          • Developing Practical Design and Development Plans<\/li>\n
          • Topics Addressed in DDP<\/li>\n<\/ul>\n<\/li>\n
          • \u00a0<\/strong>User Needs & Marketing Inputs<\/strong><\/li>\n
          • \n
              \n
            • What Are User Needs?<\/li>\n
            • Characteristics of Effective User Needs<\/li>\n
            • Identifying User Needs<\/li>\n
            • User Needs vs. Marketing Inputs<\/li>\n
            • Review User Needs<\/li>\n
            • Workshop Exercise: Developing User Needs<\/strong><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

              (Group Break Out)<\/strong><\/p>\n

                \n
              • Design Input Development<\/strong>\n
                  \n
                • What Are Design Inputs?<\/li>\n
                • Characteristics of Design Inputs<\/li>\n
                • Purpose of Design Inputs<\/li>\n
                • Design Inputs vs. User Needs<\/li>\n
                • Intended Use<\/li>\n
                • The Process of Developing Effective Design Inputs<\/li>\n
                • Design Inputs & Human Factors\u00a0<\/li>\n
                • Review Design Inputs<\/li>\n
                • Workshop Exercise: Develop Design Inputs (Group Break Out)<\/strong><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

                  \u00a0<\/strong>Risk Management Planning<\/strong><\/p>\n

                    \n
                  • \n
                      \n
                    • How to perform risk planning<\/li>\n
                    • Examples<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

                      \u00a0<\/strong>Lunch<\/strong>\u00a0<\/strong><\/p>\n

                      5) Phase II<\/strong><\/p>\n

                        \n
                      • Preliminary Design <\/strong><\/li>\n
                      • Preliminary Hazard Analysis<\/strong>\n
                          \n
                        • What is a Preliminary Hazard Analysis and why is it important?<\/li>\n
                        • Elements of a Preliminary Hazard Analysis<\/li>\n
                        • Preliminary Hazard Analysis Exercise<\/li>\n<\/ul>\n<\/li>\n
                        • Detail Design and Development \/ Testing<\/strong><\/li>\n
                        • Risk Assessment<\/strong>\n
                            \n
                          • Hazard Analysis<\/li>\n
                          • Risk Analysis<\/li>\n
                          • Risk Evaluation<\/li>\n
                          • Workshop Exercise: Performing a Risk Assessment<\/strong><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

                            (Group Break Out)<\/strong><\/p>\n

                              \n
                            • Risk Mitigation and Control<\/strong>\n
                                \n
                              • Identifying Risk Controls and Implementation<\/li>\n
                              • Workshop Exercise: Implementing Risk Controls<\/strong><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

                                (Group Break Out)<\/strong><\/p>\n

                                  \n
                                • Design Reviews <\/strong>\n
                                    \n
                                  • Purpose of Design Reviews<\/li>\n
                                  • Reviewer Roles<\/li>\n
                                  • Documenting Design Reviews<\/li>\n
                                  • Formal vs. Informal Reviews<\/li>\n
                                  • Types of Design Reviews<\/li>\n
                                  • Characteristics of Effective Design Reviews<\/li>\n
                                  • Practical Implementation and Best Practices<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

                                    <\/h3>\n

                                    Day Two<\/strong><\/h3>\n
                                      \n
                                    • Design Output <\/strong>\n
                                        \n
                                      • What are Design Outputs?\u00a0What are\u00a0Essential Design Outputs?<\/li>\n
                                      • Effectively Documenting Design Outputs<\/li>\n
                                      • What is the Device Master Record?<\/li>\n
                                      • Exercise: Identifying Design Outputs<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

                                         <\/p>\n

                                          \n
                                        • Design Verification<\/strong>\n
                                            \n
                                          • Purpose of Design Verification<\/li>\n
                                          • Types of Verification<\/li>\n
                                          • Verification Planning<\/li>\n
                                          • Documenting Verification: Protocol and Report Designs<\/li>\n
                                          • Practical Implementation and Best Practices<\/li>\n
                                          • Workshop Exercise: Effectively Plan and Execute Verification<\/strong><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

                                            (Group Break Out)<\/strong><\/p>\n

                                            \u00a0<\/strong>Design Transfer Planning & Initial Design Transfer Activities (Phase I&II)<\/strong><\/p>\n

                                              \n
                                            • \n
                                                \n
                                              • Purpose of Design Transfer<\/li>\n
                                              • Three Key Components of Effective Design Transfer Procedures<\/li>\n
                                              • Documenting Design Transfer Activities and Deliverables<\/li>\n
                                              • Design Transfer: It’s a Process, Not an Event!<\/li>\n
                                              • The Design Transfer Process: Planning, Execution, Qualification<\/li>\n
                                              • The Design Transfer Team and Design Transfer\u00a0Reviews<\/li>\n
                                              • Practical Implementation and Best Practices<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

                                                \u00a0<\/strong>\u00a0<\/strong>\u00a0<\/strong>6) Phase III (Design Transfer)<\/strong><\/p>\n

                                                  \n
                                                • Final Design Transfer \/ Final Execution (Phase 3)<\/strong><\/li>\n<\/ul>\n

                                                  \u00a0<\/strong>\u00a0<\/strong>Lunch<\/strong><\/p>\n

                                                  \u00a0<\/strong>\u00a0<\/strong>7) Phase IV<\/strong><\/p>\n

                                                    \n
                                                  • Design Validation<\/strong>\n
                                                      \n
                                                    • Purpose of Design Validation<\/li>\n
                                                    • What Is Design Validation?<\/li>\n
                                                    • Validation vs. Verification (What’s\u00a0the difference?)<\/li>\n
                                                    • Types of Validation<\/li>\n
                                                    • Is Process Validation a Part of Design Validation?<\/li>\n
                                                    • Validation Planning & Human Factors: A Risk Based Approach<\/li>\n
                                                    • Documenting Validations: Protocol and Report Designs<\/li>\n
                                                    • Practical Implementation and Best Practices<\/li>\n
                                                    • Workshop Exercise: Design Validation (Group Break Out)<\/strong><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

                                                      \u00a0<\/strong>Final Risk Assessment Verification: Effectiveness<\/strong><\/p>\n

                                                        \n
                                                      • Risk Management Report<\/strong>\n
                                                          \n
                                                        • What is included in a risk management report?<\/li>\n<\/ul>\n<\/li>\n
                                                        • Risk Management: Production and Post-Production Information<\/strong>\n
                                                            \n
                                                          • Implementing a production and post-post production feedback process<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

                                                            \u00a0<\/strong>\u00a0<\/strong>8) Phase V<\/strong><\/p>\n

                                                              \n
                                                            • Regulatory Submission & Approval<\/strong><\/li>\n
                                                            • Commercialization & Product Launch<\/strong><\/li>\n<\/ul>\n

                                                              \u00a0<\/strong>9)\u00a0\u00a0 Design History File<\/strong><\/p>\n

                                                                \n
                                                              • Purpose of the Design History File<\/li>\n
                                                              • Contents of a Design History File and Record<\/li>\n
                                                              • DHF vs. DMR vs. DHR<\/li>\n
                                                              • DHF vs. Technical File vs. 510k<\/li>\n<\/ul>\n

                                                                \u00a0<\/strong>10) Design Change<\/strong><\/p>\n

                                                                  \n
                                                                • Purpose of Design Change<\/li>\n
                                                                • Document Control vs. Change Control<\/li>\n
                                                                • When Should Design Change Begin?<\/li>\n
                                                                • Design Change Process (Development vs. Production)<\/li>\n
                                                                • Elements of Effective Design Change<\/li>\n
                                                                • Practical Implementation, Best Practices, and Examples<\/li>\n<\/ul>\n

                                                                  \u00a011) Question and Answer Session \/ Course Evaluation<\/strong><\/p>\n

                                                                  \u00a0<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

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