Monitoring Medical Device / ISO 14155 GCP

Time: 1:00pm-2:30pm, EDT US
Duration: 90 Minutes - Online
Price: $299 - Includes Bonus Handouts!

Course Description:

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 live 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

Who Should Attend:

This course will be of benefit to anyone that has a foundation in GCP, and is looking to apply that knowledge to medical device trials using the ISO 14155:2011 standard (global and domestic).  Also, those involved in establishing standard operating procedures (SOPs) for investigational sites, auditing investigative sites, or training sites on global medical device clinical quality standards will find this course particularly useful.  Finally, those who need to be conversant in the relationship between traditional GCP mandates for site monitoring vs. the ISO standard will find this course beneficial.

Sandra “SAM” Sather is an industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 25 years of clinical experience, with a Bachelor of Science in Nursing and a Master of Science in Education with a Specialization in Training and Performance Improvement. SAM is the vice-president of Clinical Pathways, a consulting firm located in the Research Triangle Park area in North Carolina, USA. SAM is dual certified by the Association for Clinical Research Professionals (ACRP) for over 10 years (CCRA and CCRC) and a current member of the ACRP Academy Board of Trustees and Regulatory Affairs Committee (RAC).  She is a frequent speaker for industry conferences and has authored dozens of courses for clinical research in various functional areas (e.g., monitoring, safety, HIPAA, and vendor management).