With the recent ICH E6 changes to include Quality Management in the conduct of clinical trials, it is important for companies to understand how to implement Quality Management – which includes Risk-Based Monitoring (RBM) – into their studies. As with any change in procedures and workflow, an adequate change management plan is crucial to ensure a smooth transition. A change management plan is also critical to the success of a risk-based Quality Management program. Without it the program will fail.
The purpose of this session is to help you develop and implement a change management strategy that eases the burden of transition.
During this course you will learn:
- How to assess if your organization is ready to implement a risk-based Quality Management program
- Various strategies to developing a Change Management Plan
- What the key elements are in a Change Management Plan
- The steps to implement a Change Management Plan