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The updated ISO 14155:2020 – GCPs for Medical Devices standard – has arrived as of July 2020. For medical device and combination product clinical researchers, compliance with (and training for) the standard is required. The latest revision aligns with regulatory changes in industry, including the European Medical Devices Regulation and recent guidance from FDA. It includes more robust guidance on risk-based monitoring, clinical quality management, and auditing. Several annexes have been added to detail new elements.
This webinar will provide you with a comparison of the 2011 and 2020 versions of ISO 14155 to assist you with gap analysis, process improvement, and updates for your clinical trial quality systems. This course also provides guidance to ensure oversight, adequate monitoring, and quality conduct of your medical device trial to meet the updated standard.
Attend this interactive live session and you will be able to:
· Describe the ISO 14155: 2020 Medical Device GCP Standard changes
· Apply ISO 14155: 2020 to study activities for sponsors, CROs and sites
· Use the comparison to identify gaps in your current processes
WHO SHOULD ATTEND
This course will be of benefit to anyone working at a site, sponsor, and CRO on medical device and combination products clinical trials.
Vidia Ramdeen MPA SSBB is a research consultant with experience across a broad array of industries including health care, medical, biomedical, and biotechnology. In addition, his research experience includes strategy, innovation, leadership, solutions-based, and management consulting. His knowledge of compliance issues is a function of consulting responsibilities that provide a fundamental base to analyze today’s complex compliance environment.