Webinar on “Performing Root Cause Analysis in Risk-based Monitoring (RBM)”

Pharmaceutical Regulatory Affairs                                           

Risk assessment and risk management are the two important aspects of risk-based monitoring. RBM is all about taking holistic approach to assess all possible risks and then have a proper plan for risk management. Effective risk action planning involves effective root cause analysis (RCA) as part of risk mitigation. Therefore, it is necessary to identify thoroughly root causes and sources of all potential risks, as well as root causes of failed risk mitigation to improve action planning.  Effective RCA helps to build a robust action plan for mitigation of risks.

This session includes more than the tools common to RCA, but also the scientific concepts of root cause analysis applied directly to clinical quality risk management practices with an outcome of tools specific for application in risk-based monitoring.

 Key topics

  • How to integrate root cause analysis to risk-based monitoring
  • How to implement RCA processes that work with sponsors, sites and CROs
  • Interventions based on RCA, for risk diagnostic process, action planning and revisions


Sandra “SAM” Sather, MS, BSN, CCRA, CCRC
VP, Clinical Pathways, LLC
North Carolina, USA



Ashok K. Ghone, PhD
VP, Global Services
MakroCare, USA

Ashok Ghone

Date & Time:

Date: Thursday, 20 February, 2014


08.00 -09.00 hrs  PST
11.00 – 12.00 hrs EST

CET (Central European Time):
17.00 – 18.00 hrs CET

Cost : None

 For more details sent an e-mail to webinar@makrocare.com

Click Here

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