Good Clinical Practice ISO 14155 for Medical Devices

🎓 Complete ISO GCP Course on Clinical Investigations with Medical Devices for Clinical Research Professionals 🏫

Course Headline:

Welcome to this complete edition of the ISO 14155 GCP course on Clinical Investigations with Medical Devices!

Introduction to the Course: This course stands as the first professional, detailed course tailored specifically for Investigators, Study Coordinators, Sponsors, Clinical Project Managers, Monitors, and any other Clinical Study staff who are keen on mastering the intricacies of Good Clinical Practice (GCP) in the context of medical devices. Rest assured, this GCP course is meticulously maintained up-to-date with upcoming revisions as they become available.

Instructor's Introduction: My name is Dr. Vincent Baeyens PhD, and I bring to the table over 20 years of hands-on experience in running Clinical Trials within Global and mid-size Pharma, Biotech settings, as well as a profound expertise in CRO Management and Oversight, budgeting, and Risk Management.

Course Content Overview: Throughout this course, you will gain an in-depth understanding of ISO GCP requirements tailored for clinical trials involving Medical Devices. We will delve into the role and responsibilities of key stakeholders, with a focus on making the content accessible even for beginner students by dividing it into concise lectures.

Key Learning Outcomes:

• Understanding Medical Devices: Learn what constitutes a Medical Device and its significance in clinical trials.
• Regulatory Framework: Grasp the regulatory framework of ISO 14155 and how it applies to clinical investigations.
• Common Audit/Inspection Findings: Identify common issues during audits or inspections related to sponsors or investigators.
• Scope of ISO 14155: Determine the scope of ISO 14155 and its relevance to your clinical research.
• ISO 14155 GCP Principles: Understand the core principles of ISO 14155 GCP, ensuring ethical and compliant study execution.
• Ethics Committees & Compliance: Learn about the responsibilities of ethics committees, principal investigators, and sponsors in clinical trials.
• Planning a Clinical Investigation: Acquire the skills to effectively plan a clinical investigation.
• Conducting a Clinical Investigation: Discover the key steps for conducting a successful clinical investigation.
• Audit/Inspection Readiness: Focus on what it takes to be ready for an audit or inspection.
• Anticipating Deviations: Learn how to anticipate and handle potential deviations from ISO 14155 GCPs.

Course Format: This course is designed to provide a comprehensive learning experience, culminating in a final Quiz that will solidify your understanding of the material covered.

Personalized Support: As your instructor, I am committed to providing you with the support you need. You can reach out to me at any time during the course for questions or clarifications. My personal involvement ensures that you receive the guidance necessary for a thorough understanding of ISO 14155 GCP.

Course Content Note: Please note that, for copyright reasons, I am unable to share the actual text of the ISO 14155 norm within this course platform. However, the principles and practices covered are designed to align with the standard and provide you with a robust understanding of the requirements.

Course Invitation: I invite you to explore the content of the course further to appreciate the depth and breadth of knowledge it imparts. If you have any questions or need additional information, feel free to contact me. I am here to ensure that your learning journey is as enriching as possible.

Conclusion: I look forward to guiding you through this transformative learning experience and welcome you to join our community of informed clinical research professionals dedicated to maintaining the highest standards in GCP for Medical Devices.

Sincerely, Vincent Baeyens PhD