ISO 14155 Complete Self-Assessment Checklist and Audit Preparation Course Curriculum
Course Overview This comprehensive course is designed to equip participants with the knowledge and skills necessary to understand and implement the ISO 14155 standard for clinical investigation of medical devices. Upon completion, participants will receive a Certificate of Completion issued by The Art of Service.
Course Outline The course is divided into the following modules: - Module 1: Introduction to ISO 14155
- Overview of the ISO 14155 standard
- History and evolution of the standard
- Importance of ISO 14155 in clinical investigations
- Key principles and concepts
- Module 2: Clinical Investigation Principles
- Principles of clinical investigations
- Ethical considerations
- Risk management and mitigation
- Clinical investigation planning
- Module 3: Clinical Investigation Protocol
- Development of a clinical investigation protocol
- Protocol content and structure
- Protocol review and approval
- Protocol amendments and changes
- Module 4: Clinical Investigation Conduct
- Conducting clinical investigations
- Data collection and management
- Monitoring and auditing
- Dealing with deviations and non-compliance
- Module 5: Clinical Investigation Reporting
- Clinical investigation reporting requirements
- Report content and structure
- Report review and approval
- Report dissemination and sharing
- Module 6: Clinical Investigation Auditing
- Auditing clinical investigations
- Audit planning and preparation
- Audit conduct and reporting
- Audit follow-up and closure
- Module 7: ISO 14155 Self-Assessment Checklist
- Using the ISO 14155 self-assessment checklist
- Identifying gaps and areas for improvement
- Developing a corrective action plan
- Implementing changes and improvements
- Module 8: Audit Preparation
- Preparing for an ISO 14155 audit
- Understanding audit requirements
- Gathering evidence and documentation
- Conducting a pre-audit review
- Module 9: Case Studies and Group Exercises
- Real-world case studies and examples
- Group exercises and discussions
- Applying ISO 14155 principles to real-world scenarios
- Sharing experiences and best practices
Course Features This course is designed to be: - Interactive: Engaging and participatory, with opportunities for discussion and feedback
- Comprehensive: Covering all aspects of ISO 14155 and clinical investigations
- Personalized: Tailored to meet the needs and goals of individual participants
- Up-to-date: Reflecting the latest developments and best practices in clinical investigations
- Practical: Focusing on real-world applications and scenarios
- High-quality content: Developed and delivered by expert instructors
- Certification: Participants receive a Certificate of Completion upon finishing the course
- Flexible learning: Self-paced and accessible on a variety of devices
- User-friendly: Easy to navigate and use, with clear instructions and support
- Mobile-accessible: Accessible on-the-go, on a variety of mobile devices
- Community-driven: Opportunities for discussion and collaboration with other participants
- Actionable insights: Providing practical takeaways and recommendations for improvement
- Hands-on projects: Applying ISO 14155 principles to real-world scenarios
- Bite-sized lessons: Breaking down complex topics into manageable chunks
- Lifetime access: Access to course materials and resources for a lifetime
- Gamification: Using game design elements to enhance engagement and motivation
- Progress tracking: Monitoring progress and achievement throughout the course
Course Benefits By completing this course, participants will be able to: - Understand the principles and requirements of ISO 14155
- Develop and implement a clinical investigation protocol
- Conduct and manage clinical investigations
- Report and disseminate clinical investigation results
- Audit and assess clinical investigations
- Prepare for an ISO 14155 audit
- Apply ISO 14155 principles to real-world scenarios
,
- Module 1: Introduction to ISO 14155
- Overview of the ISO 14155 standard
- History and evolution of the standard
- Importance of ISO 14155 in clinical investigations
- Key principles and concepts
- Module 2: Clinical Investigation Principles
- Principles of clinical investigations
- Ethical considerations
- Risk management and mitigation
- Clinical investigation planning
- Module 3: Clinical Investigation Protocol
- Development of a clinical investigation protocol
- Protocol content and structure
- Protocol review and approval
- Protocol amendments and changes
- Module 4: Clinical Investigation Conduct
- Conducting clinical investigations
- Data collection and management
- Monitoring and auditing
- Dealing with deviations and non-compliance
- Module 5: Clinical Investigation Reporting
- Clinical investigation reporting requirements
- Report content and structure
- Report review and approval
- Report dissemination and sharing
- Module 6: Clinical Investigation Auditing
- Auditing clinical investigations
- Audit planning and preparation
- Audit conduct and reporting
- Audit follow-up and closure
- Module 7: ISO 14155 Self-Assessment Checklist
- Using the ISO 14155 self-assessment checklist
- Identifying gaps and areas for improvement
- Developing a corrective action plan
- Implementing changes and improvements
- Module 8: Audit Preparation
- Preparing for an ISO 14155 audit
- Understanding audit requirements
- Gathering evidence and documentation
- Conducting a pre-audit review
- Module 9: Case Studies and Group Exercises
- Real-world case studies and examples
- Group exercises and discussions
- Applying ISO 14155 principles to real-world scenarios
- Sharing experiences and best practices
Course Features This course is designed to be: - Interactive: Engaging and participatory, with opportunities for discussion and feedback
- Comprehensive: Covering all aspects of ISO 14155 and clinical investigations
- Personalized: Tailored to meet the needs and goals of individual participants
- Up-to-date: Reflecting the latest developments and best practices in clinical investigations
- Practical: Focusing on real-world applications and scenarios
- High-quality content: Developed and delivered by expert instructors
- Certification: Participants receive a Certificate of Completion upon finishing the course
- Flexible learning: Self-paced and accessible on a variety of devices
- User-friendly: Easy to navigate and use, with clear instructions and support
- Mobile-accessible: Accessible on-the-go, on a variety of mobile devices
- Community-driven: Opportunities for discussion and collaboration with other participants
- Actionable insights: Providing practical takeaways and recommendations for improvement
- Hands-on projects: Applying ISO 14155 principles to real-world scenarios
- Bite-sized lessons: Breaking down complex topics into manageable chunks
- Lifetime access: Access to course materials and resources for a lifetime
- Gamification: Using game design elements to enhance engagement and motivation
- Progress tracking: Monitoring progress and achievement throughout the course
Course Benefits By completing this course, participants will be able to: - Understand the principles and requirements of ISO 14155
- Develop and implement a clinical investigation protocol
- Conduct and manage clinical investigations
- Report and disseminate clinical investigation results
- Audit and assess clinical investigations
- Prepare for an ISO 14155 audit
- Apply ISO 14155 principles to real-world scenarios
,
- Understand the principles and requirements of ISO 14155
- Develop and implement a clinical investigation protocol
- Conduct and manage clinical investigations
- Report and disseminate clinical investigation results
- Audit and assess clinical investigations
- Prepare for an ISO 14155 audit
- Apply ISO 14155 principles to real-world scenarios