Quality Management Essential Training

Quality Management Essential Training
for Clinical Trial Staff

Afrileadtech School of Clinical Research and AuditVantage Solutions (AVS) improve clinical trial operational quality by collaborating with Akanksha Jain, an RQAP-GCP-certified auditor.
Essential training for clinical trial staff in Quality Management (QM) focuses on establishing systems that protect participant safety and ensure the reliability of trial data.

Enrol Now – R4,200 Place Order
6 hours self-paced · Online quiz + practical assignment · Official certificate
Program highlights
  • 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

Who should train

This course is tailored for professionals working in clinical research operations, quality management, and regulatory oversight who wish to strengthen their knowledge of audit readiness, quality systems, and compliance in clinical trials. It provides clinical research staff with a solid foundation in quality management principles essential to regulatory compliance, data integrity, and patient safety.
The training modules address critical areas such as risk management, issue resolution, root cause analysis, and the design of corrective and preventive actions.
By equipping participants with practical skills in audit preparation, hosting, and closure, the program supports regulatory compliance while fostering a culture of continuous improvement.

Clinical quality training

📘 What the Course Covers

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 & Impact Analysis
Corrective & Preventive Action Plan (CAPA)
Basics of Audit Preparation, Hosting & Closure

Akanksha Jain

RQAP-GCP™ | Lead Auditor ISO 13485:2016

Meet the trainer

Akanksha Jain is an RQAP-GCP certified1 and a certified Lead Auditor 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 that simplify 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 training sessions and webinars to promote practical quality management.

🎓 How the Training is Offered

The training is delivered through a six-hour virtual program hosted on our dynamic interactive platform. It combines instructor-led sessions with engaging elements such as quizzes, assignments, and assessments to ensure a thorough understanding.
Participants are expected to take the course, dedicate the required time, complete all assignments, and be prepared to apply the lessons learned in practice.
Virtual training session
Secure online registration through Afrileadtech portal

R4,200 (incl. VAT)

  • Duration: 6 hours (self-paced)
  • Assessment: Online quiz + practical assignment
  • Certification: Certificate issued upon successful assignment completion
  • Globally recognized credential
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