Central Monitoring GCP ICH

We will share an example of output that a central monitor might see and work together to investigate to determine if there is an issue and then try to determine the root causes. We will use the D-I-G-R root cause analysis method and show how it is more effective than the overly simplified „Five Whys.“ Come along to take part – or just listen and learn.

ABOUT „mindsON RBQM“ WORKSHOPS

mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialogue 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.  

Eventdatum: Mittwoch, 11. Dezember 2024 17:00 – 18:00

Eventort: Online

Some companies have been early adopters of RBQM methodology, and others have been laggards. What evidence is there of added value to the early adopters?

ABOUT „mindsON RBQM“ WORKSHOPS

mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialogue 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. 

Eventdatum: Mittwoch, 13. November 2024 17:00 – 18:00

Eventort: Online

We will share a simplified example of a protocol outline, along with high-risk items that we want to reduce. How should you go about reducing risks? What is a mitigation, a risk control and a contingency? Will you get the same answers as our RBQM experts? Come along to take part – or just listen and learn.

ABOUT „mindsON RBQM“ WORKSHOPS

mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialogue 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.

Eventdatum: Dienstag, 17. September 2024 17:00 – 18:00

Eventort: Online

We will share a simplified example of a protocol outline, brainstorm, and evaluate risks. Will you get the same answers as our RBQM experts? Come along to take part—or just listen and learn.

ABOUT „mindsON RBQM“ WORKSHOPS

mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialogue 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. 

Eventdatum: Donnerstag, 27. Juni 2024 17:00 – 18:00

Eventort: Online

An area of much debate (and confusion) is the differences, similarities, and overlaps between Risk-Based Quality Management, Quality by Design, Centralized Monitoring, Centralized Statistical Monitoring, Remote Monitoring, and Risk-Based Monitoring. Or, in the alphabet soup of our industry, RBQM, QbD, CM, CSM, RM and RBM. At this workshop, our industry experts will provide their perspectives and get the perspectives of those in the audience. Is the industry settling on definitions for these terms, or will the confusion persist?

ABOUT „mindsON RBQM“ WORKSHOPS

mindsON RBQM is a series of workshops by Cyntegrity’s MyRBQM Academy that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialogue and problem-solving exercises. We invite you to share your experiences and participate in the interactive dialog with our well-known industry experts, Johann Proeve (PhD) and Keith Dorricott (MBB). If you prefer to listen and observe, that’s okay as well. 

Eventdatum: Mittwoch, 29. Mai 2024 17:00 – 18:00

Eventort: Online