The RBQM Essentials White Belt course is dedicated to the fundamental RBQM knowledge you and your team must have before developing your RBQM strategy.
What if… you could implement your RBQM strategy effectively and efficiently, have your teams embrace the process and contribute to its success while being confident that your strategy has the key components it needs to meet regulatory expectations?
RBQM Essentials is a series of courses that goes beyond the basics of the regulations and gives you change management strategies, team effectiveness tools and downloadable implementation tools you can use immediately, and takes you step-by-step through the key components you need to have in your risk-based quality management strategy.
Clinical researchers who earn RBQM Essentials certification become key stakeholders in improving the output of clinical operations within their organizations. They strive to optimize data quality and patient safety in clinical trial conduct by implementing risk-based processes and establishing metrics, KRIs, KPIs, and QTLs, that minimize the potential for error, misconduct and fraud.
Who should attend?
- Clinical Operation Managers, Data managers and Clinical Project Managers
- Prior experience in and/or knowledge of ICH-GCP and Clinical Research is recommended
Why should you attend?
- Gain a certification to advance your career
- Learn an essential skill to improve your prospect
- Achieve compliance in your industry
RBQM Essentials – Belt Level Rankings
But what do RBQM Essentials belt levels mean? These certifications indicate the roles that individuals are qualified to play in conducting clinical trials and tutoring risk-based quality management practices. RBQM Essentials’ belt certifications equip clinical research professionals to be active participants in optimizing their company quality culture and avoiding downtime.
Get to know each of the rankings so you can build skills that will help your organization function more smoothly and advance your career:
White Belt: 100% online & self-paced
You are considered RBQM Essentials ‘White Belt‘ if you have not yet undergone an instructor-led classroom training or extended training. An online course with an overview of relevant regulations, concepts, methods and vocabulary for risk-based quality management shows you how you can contribute to efficient, reliable clinical outcomes. With this basic grounding, White Belts participate in clinical research and problem-solving tasks related to quality management and risk reduction. Take a sneak peek…
CURRICULUM: RBQM Essentials White Belt Course (90 minutes)
Lecture 1. Understanding RBQM
- Introduction to RBQM Essentials White Belt course
- What is Risk-Based Quality Management?
- Why is RBQM essential to successful clinical trial conduct?
- What is the main purpose of RBQM?
- Quiz Lecture 1
Lecture 2. Taking a ‘Risk-Based Approach’
- What does it mean ‘taking a risk-based approach’?
- What are the new risk-based Monitoring methods, types and roles?
- What is the difference between Targeted and Triggered Monitoring?
- What are the key aspects of an RBQM Plan?
- Quiz Lecture 2
Lecture 3. Perspectives to Approach Risk
- What is ‘Quality by Design’?
- What is the concept of ‘Design Space’?
- What is ‘risk’ and its properties?
- What are the different clinical risk categories and types?
- Quiz Lecture 3
Lecture 4. Practical Considerations
- What does it take to develop and implement risk-based quality management?
- Who are involved in RBQM?
- How can workflows be managed?
- What is ‘holistic RBQM’?
- Quiz Lecture 4
Lecture 5. The RBQM Toolbox
- What are the key elements of RBQM implementation?
- Which tools and technologies are ‘fit-for-purpose’?
- What are the benefits of specialized RBQM tools?
- Quiz Lecture 5
Lecture 6. Let’s Ask the Experts
- RBQM Myth 1 – 5 (popular misconceptions)
- Quiz Lecture 6