Quality Management Essential Training for Clinical Trial Staff

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About Course

This training is essential for clinical research staff, as it provides a comprehensive foundation in quality management principles that are crucial for ensuring compliance, safeguarding data integrity, and supporting patient safety. The modules cover key areas such as risk management, issue resolution, root cause analysis, and the development of corrective and preventive actions. By equipping participants with practical skills in audit preparation, hosting, and closure, the programme helps staff maintain regulatory standards and fosters a culture of continuous improvement. Ultimately, this training empowers clinical research teams to deliver robust, high-quality studies that meet global expectations and withstand regulatory scrutiny. The Training covers:

  • Introduction to Quality Management System
  • Basics of Quality Risk Management
  • Quality Issues (QIs) Management
  • Root Cause Analysis (RCA) and Impact Analysis
  • Corrective and Preventive Action Plan (CAPA)
  • Basics of Audit Preparation, Hosting & Closure
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What Will You Learn?

  • By the end of this course, you will gain a practical understanding of quality management and audit readiness in clinical trials and how these processes ensure participant safety, data integrity, and regulatory compliance.
  • You will learn:
  • Fundamentals of Quality Management Systems (QMS) and their role in clinical research quality oversight.
  • Quality Risk Management principles, including how to proactively identify, analyse, and mitigate risks in clinical trial processes to protect participants and ensure reliable data.
  • 14.2 Basics of Quality Risk Assessment
  • Quality Issue Management, including how to define problems, investigate deviations, and assess their impact on participant safety, regulatory compliance, and data integrity.
  • 14.3 Quality Issue Management
  • Root Cause Analysis techniques, such as the 5 Whys and Fishbone (Ishikawa) method, to systematically identify underlying causes of clinical trial issues.
  • 14.4 Root Cause Analysis & Impa…
  • Corrective and Preventive Action (CAPA) planning, enabling you to develop effective, measurable, and sustainable solutions to prevent issues from recurring.
  • 14.5 CAPA
  • Audit preparation, hosting, and closure, including how to prepare your site for audits, manage auditor interactions, and respond appropriately to audit findings.
  • 14.6 Basics of Audit Preparation
  • Best practices for maintaining inspection-ready clinical trial sites, ensuring that documentation, processes, and staff responsibilities meet regulatory expectations.
  • By the end of the course, you will be equipped with practical tools, frameworks, and strategies to strengthen quality oversight, improve compliance with ICH-GCP and regulatory requirements, and confidently prepare for clinical trial audits and inspections.

Course Content

Quality Management Essential Training for Clinical Trial Staff
Quality Management Essential Training for Clinical Trial Staff This training is essential for clinical research staff, as it provides a comprehensive foundation in quality management principles that are crucial for ensuring compliance, safeguarding data integrity, and supporting patient safety. The modules cover key areas such as risk management, issue resolution, root cause analysis, and the development of corrective and preventive actions. By equipping participants with practical skills in audit preparation, hosting, and closure, the programme helps staff maintain regulatory standards and fosters a culture of continuous improvement. Ultimately, this training empowers clinical research teams to deliver robust, high-quality studies that meet global expectations and withstand regulatory scrutiny. The Training covers: • Introduction to Quality Management System • Basics of Quality Risk Management • Quality Issues (QIs) Management • Root Cause Analysis (RCA) and Impact Analysis • Corrective and Preventive Action Plan (CAPA) • Basics of Audit Preparation, Hosting & Closure The trainer ( Short Bio) Akanksha Jain is anRQAP-GCP certified1 and also a certified Lead Auditor Certificate in Quality Management Systems for Medical Devices (ISO 13485:2016) with over 16 years of clinical research experience, having conducted more than 400+GCP audits across four continents and 15 countries. . She has held leadership roles at AstraZeneca, Glenmark, and IQVIA, and since July 2023 is working as a freelance GCP Auditor, Quality Consultant, and Trainer. In January 2025, she founded AuditVantage Solutions (AVS) to provide expert GCP auditing, quality consulting, and training services focused on simplifying quality frameworks while upholding global standards. Akanksha specialises in audit execution, actionable insights, inspection readiness, RCA, and CAPA effectiveness, and has delivered more than 500+ trainings and webinars to promote practical quality management.

  • Introduction to Quality Management System
    42:00
  • Basics of Quality Risk Management
    34:00
  • Quality Issues (QIs) Management
    42:00
  • Root Cause Analysis (RCA) and Impact Analysis
    39:00
  • Corrective and Preventive Action Plan (CAPA)
    32:00
  • Basics of Audit Preparation, Hosting & Closure
    33:00
  • Quiz Quality Management Essential Training for Clinical Trial Staff
  • Assignment Candy001
  • Candy001 Assignment Quiz

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