Session 6 - Risked Based Quality Management – It Takes a Village!
Tuesday, September 15, 2020: 11:15 AM - 12:15 PM
/ CEU Credits:0.2
SESSION CHAIRS & SPEAKERS
The clinical research industry is ever evolving. With constant changes from updated regulations and new technologies popping like popcorn, it truly takes a village to raise a product from concept to market. This village must house all of the components necessary for a successful Risk Based Quality Management strategy. Risk Based Quality Management (RBQM) is more than risk based monitoring - it is a comprehensive approach to evaluating overall trial risks, with documented measures put in place to manage those risks.
In this session, a panel of industry professionals will discuss ways the various members of this village – project management, corporate operations, data management, and others – can work together to form a holistic RBQM strategy. Learn from the experts what works, what doesn’t, and how you can implement a RBQM strategy for your next medical discovery.
1. RBQM Definition
2. RBQM Accountability Responsibilities
3. RBQM Critical Components
4. RBQM Implementation
CDM Certification Competencies::
Project Management,Clinical Trials Processes, Roles, and Responsibilities,CRF Design
DM Management,Data Managers,Clinical Operations,Project Managers