MyRBQM® Academy | Webinars

The process for RBQM in clinical trials described in Section 5.0 of ICH E6(R2) starts with identifying critical processes and data. What are the leading practices for identifying these critical processes and data? Is it best to start with critical processes or with critical data? How can you use critical endpoints to identify critical data? Should you identify the underlying processes for the capture and accuracy of critical data? Join us at this live workshop as our two experts provide their perspectives on these questions and, if you’d like, take the opportunity to ask your questions, brainstorm examples, and join the discussion.

Step 2 of the process for RBQM in clinical trials described in Section 5.0 of ICH E6(R2) is to identify risks to the critical processes and data. It describes identifying risks at the system and trial levels. What are the leading practices for identifying these risks? How do you identify potential issues that haven’t yet occurred? How many risks is it reasonable to identify? Risk statements have been suggested as being helpful, but how do they work? Join us at this live workshop as our two experts provide their perspectives on these questions and, if you’d like, take the opportunity to ask your questions, brainstorm examples, and join the discussion.

Step 3 of the process for RBQM in clinical trials described in Section 5.0 of ICH E6 R2 is to evaluate risks against the existing risk controls. What are the leading practices for evaluating these risks? How can you assess the likelihood, impact, and detectability of potential issues? How are existing controls defined? How is it best to think of the concept of detectability? Join us at this live workshop as our two experts provide their perspectives on these questions and, if you’d like, take the opportunity to ask your questions, brainstorm examples, and join the discussion.

About "mindsON Going Risk-Based" workshops: mindsON Going Risk-Based is a series of workshops that provides practical advice on the challenging aspects of evolving to a new way of working through a phased program approach. Each workshop allows room for interactive dialog and problem-solving exercises. We invite you to share your own experiences and participate in the interactive dialog. If you prefer to listen and observe, that's okay as well.

Step 4 of the process for RBQM in clinical trials described in Section 5.0 of ICH E6(R2) is to control the identified risks to an acceptable level. It provides examples of risk reduction activities and introduces Quality Tolerance Limits. What are the leading practices for controlling these risks? How can you ensure risk controls are implemented? How do you know if the controls are effective? Where do Key Risk Indicators and Quality Tolerance Limits fit in? Join us at this live workshop as our two experts provide their perspectives on these questions and, if you’d like, take the opportunity to ask your questions, brainstorm examples, and join the discussion.

About "mindsON Going Risk-Based" workshops: mindsON Going Risk-Based is a series of workshops that provides practical advice on the challenging aspects of evolving to a new way of working through a phased program approach. Each workshop allows room for interactive dialog and problem-solving exercises. We invite you to share your own experiences and participate in the interactive dialog. If you prefer to listen and observe, that's okay as well.

Steps 5 and 6 of the process for RBQM in clinical trials described in Section 5.0 of ICH E6(R2) are to communicate quality management activities and review risk control measures periodically. What are the leading practices in this area? Who should you communicate risk controls to? And how? When should risk reviews take place? Should all risks be reviewed or only the high-priority ones? Join us at this live workshop as our two experts provide their perspectives on these questions and, if you’d like, take the opportunity to ask your questions, brainstorm examples, and join the discussion.

Section 5.20.1 of ICH E6(R2) refers to root cause analysis for significant noncompliances in clinical trials. What are the leading practices in this area? Who should be involved in root cause analysis? What methods are proven to work? How does root cause analysis relate to corrective and preventive actions? And what’s the difference between a corrective and a preventive action anyway? Join us at this live workshop as our two experts provide their perspectives on these questions and, if you’d like, take the opportunity to ask your questions, brainstorm examples, and join the discussion.

About "mindsON Going Risk-Based" workshops: mindsON Going Risk-Based is a series of workshops that provides practical advice on the challenging aspects of evolving to a new way of working through a phased program approach. Each workshop allows room for interactive dialog and problem-solving exercises. We invite you to share your own experiences and participate in the interactive dialog. If you prefer to listen and observe, that's okay as well.

Section 5.20.1 of ICH E6(R2) refers to root cause analysis for significant noncompliances in clinical trials. This should lead to corrective and preventive actions. Does this relate at all to section 5.0 on Risk-Based Quality Management? After all, isn’t a risk a potential issue? And where an issue has occurred, the actions taken to reduce the likelihood or impact of recurrence are risk controls, aren’t they? Can you use historical data on issues to help with risk evaluation and control? Join us at this live workshop as our two experts provide their perspectives on these questions and, if you’d like, take the opportunity to ask your questions, brainstorm examples, and join the discussion.