The ISO 14155: 2011 Clinical Investigation of Medical Devices for Human Subjects — Good Clinical Practice has been well received as a global standard for medical device GCP, including sponsor monitoring. With the complexity of diagnostic trials and the many layers of requirements for different device classifications, having a foundational understanding of the standard and its implementation is critical to the success of your studies. This training course focuses on the application of the standard specific to the sponsor monitoring responsibilities and activities. This interactive session can be used as a foundation for training of sponsor study teams and monitors.
Attend this interactive session and you will:
- Obtain a foundational understanding of the ISO14155: 2011 Medical Device GCP Standard, with a focus on content related to sponsor site monitoring
- Be able to apply the ISO 14155:2011 Standard to study activities related to site monitoring
- Understand how to facilitate a gap analysis and implementation plan to adapt the standard into your current practices
- Learn best practices for continuous improvement, plus common pitfalls to avoid