Medical Device GCP/ISO 14155 Standard: Investigator Training
The recent revisions of ISO 14155: 2011 Clinical Investigation of Medical Devices for Human Subjects — Good Clinical Practice have been well received as a global standard for medical device GCP. This training course focuses on the ISO standard's sections specific to investigator responsibilities. The content of this training can be used as a foundation for investigator training for study responsibilities.
Attend this interactive live session and you will be able to provide:
- Training on ISO 14155: 2011 to principal investigators and others that manage investigative sites on studies that recognize the standard
- Study team members with an overview of the requirements of the standard, plusany significant differences between local requirements and the standard
- Information to facilitate a gap analysis and implementation plan to adapt the standard into current practice
This course will be of benefit to anyone working on medical device global clinical trials where the ISO 14155:2011 standard is part of the GCP foundations. Also, those involved in establishing investigational sites standard operating procedures (SOPs), and auditing investigative sites or training sites on global medical device clinical quality standards will find this course particularly useful.
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).
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