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.
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.
What the course cover
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
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.
Course Fee
R4,200
Duration
6 hours (self‑paced)
Assessment
Online quiz and practical assignment
Certification
Certificate issued upon successful assignment completion
Registration
To secure a place in the training, participants must complete the order and registration process via the designated registration link
The training is delivered by Dr Nyeleti Bicky Mthombeni (PhD), an HPCSA-accredited trainer. Dr Mthombeni brings over 18 years of experience in clinical research and has more than ten years of expertise in Good Clinical Practice (GCP) content development and training.
info@afrileadtech.co.za
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