The RBQM Essentials Black Belt training is dedicated to ensuring you have the change management strategies you and your team need to create sustainable change.
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?
- Selected staff from the group(s) that passed the Green Belt course and/or those who will be in charge of rolling out RBQM in the/an organization
Similar to the Lean Six Sigma methodology, RBQM Essentials provides the use of a colored belt tier system for its certification. To receive a belt-level certification, students must follow a hierarchical process.
NOTE: Prior MyRBQM® Academy White Belt and Green Belt certification are required (learn more…)
Why should you attend?
- Become a certified expert to advance your career
- Achieve compliance in your industry
- Join the exclusive MyRBQM® Academy Alumni community
- The bonuses beyond the course content itself…
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.
Black Belt: virtual instructor-led classes
A ‘Black Belt’ understands change management philosophies and RBQM principles, including the supporting Clinical Trial Risk Management (CTRM) systems and tools. This person demonstrates team leadership and understands all aspects of the Kübler–Ross model in accordance with RBQM principles.
Black Belts are known as agents of change within an organization. They have a deep understanding of team dynamics and handle assigning roles and responsibilities to team members. Most often these team members are Green Belts.
It is the goal of a Black Belt to improve overall quality and profitability.
How does it work?
Through an interactive approach, the webinar-style workshop will provide lessons, case studies, and hands-on sessions, allowing you to implement RBQM and change management in your daily practice. There will be room for knowledge sharing with all participants so that you will benefit not only from the trainer’s but also learn from each other’s experiences.
Our industry experts contribute to the workshops by providing their real-life experience, including a live demonstration of a Risk-based Quality Management enabling technology.
Download the full brochure here… or contact us: firstname.lastname@example.org
CURRICULUM | RBQM Essentials Black Belt Course (3 sessions of 2 hours)
- Key Risk Indicators. Part II.
- Quality Tolerance Limits
- Process integration
- Centralized Statistical Monitoring (CSM), methods, and algorithms
- Adaptive monitoring process
- How to control residual risks (the “unknown unknowns”)
- Roles and responsibilities
- Change management and dealing with resistance
- Group session: interactive risk assessment and data analysis of a generic study
The Black Belt course comes with a bonus beyond the course content itself:
Free of Charge: Adaptive Monitoring for Clinical Trials (Flowcharts)
The complete set of the Adaptive Monitoring process flowcharts including description. Risk-based Quality Management integrates the Adaptive Monitoring (AM) process, which addresses all aspects of quality risk management. The AM concept incorporates people, process, and technology yielding the greatest impact on quality, effectiveness, and cost savings.
Take a look here: https://cyntegrity.com/product/adaptive-monitoring-for-clinical-trials-flowcharts/
What are you waiting for… get your verified certificate!