ICH GCP E6 (R2): Validating Electronical Systems for Clinical Researchers

Description
Quality

Validation of electronical systems is a must in todays increased use of technology in clinical trials. It’s a complex process with many possible variations and options. In this TRIUM Session, you will learn what elements to consider and which need to be outlined in a validation SOP to ensure reliable data and audit trails from trial onset to completion or system decommissioning.

At the end, you will receive a certificate and handy hand-outs for later use.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Define electronical systems
  • List what elements need to be outlined in a validation SOP
Intended audience

Advanced Level
Demonstrates advanced skills and knowledge and the ability to teach, coach, or supervise others. Consistently applies critical thinking and problem solving.

Trainer
Esther Daemen
Esther Daemen is currently ‘Quality &Training Director – Data Protection manager’ at TRIUM Clinical Consulting and has over 27 years of working experience in the healthcare/pharma & device field. She served many organizations in different research roles and as professional development director at ACRP global. She gained a bachelor’s in nursing and earned project management, training and DPO certificates as well as and a master´s degree in Business. Esther is also a highly sought-after presenter at professional conferences/universities and a writer of peer-reviewed articles for professional magazines like ‘The Clinical Researcher’. Her work was rewarded by the KP Morgan 'OECT Summit 10Years Speaker Achievement Award' in 2020, the ‘Best trainer to watch’ 2010 Training Magazine award and by having her organization ‘Kendle’ being listed as one of the top 125 training providers in the world in 2008. "TRIUM is an expert Contract Research Organization that offers a unique combination of global CRO services, staffing solutions, quality services, GDPR consultancy and risk-based approaches as well as training services. It’s our mission to be a passionate, dedicated business partner with a focus on excellence to provide start‐to‐finish clinical trial activities tailored to the timing, budget and specific needs of the Sponsor.”