Quality is the buzzword these days in the clinical research field. But what does quality mean and how is it established? This TRIUM Training introduces the concept of quality in the context of a clinical trial’s regulated environment and explains how Quality Management Systems should be set up to ensure all elements like processes, resources, partners, risks, issues and knowledge management are interconnecting in order to avoid or mitigate high risks.
After a theoretical introduction to the skills and techniques you will have opportunity to practice and learn from you peers using real clinical research case studies and examples. A handy job aid summarizing the key take-aways will be handed out at the end of the training day to help you transform your newly learned skills into actual performance.
At the end, you will receive a certificate for attendance and handy hand-outs for use in the field.
By the end of this TRIUM Training you should be able to:
- Describe the therapy development process and its related regulations and guidelines
- Define Quality Assurance (QA), Quality Control (QC), monitoring, audits and inspections, Quality Management (QM), Quality Management System (QMS), Quality by Design (QbD), risk management and risk assessment, Root Cause Analysis (RCA), Corrective Action Preventive Action plan (CAPA)
- Critically assess clinical trial quality management strategies and related procedures and systems
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.