This training is a 2.5-hour recorded session, combining the following 30 minutes recorded webinars in a package deal with a 50% ‘corona’ reduction on the total subscription fee.
- ICH GCP E6 (R2): Build your own flexible clinical Quality Management System (QMS)
- ICH GCP E6 (R2): Validating Electronical Systems for Clinical Researchers
- ICH GCP E6 (R2): Vendor Oversight that Works
- ICH GCP E6 (R2): Root Cause Analysis and Corrective and Preventive Action: where to begin?
- ICH GCP E6 (R2): Risk Assessments and Control Skills to decide on Risk-based Monitoring Strategies.
By the end of this TRIUM Training you should be able to:
- Define Quality Management Systems; Identify the different stakeholders; Describe the foundational aspects of the setup and maintenance of a clinical QMS
- Define electronical systems; List what elements need to be outlined in a validation SOP
- Define Vendor Oversight; Describe the elements of an effective vendor oversight model; Create meaningful quality and operational metrics
- Define RCA and CAPA; Describe the different RCA and CAPA methodologies
- Define risks, risk-based monitoring techniques and plans; Describe the steps involved in conducting risk assessments
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.