Defining Risk Culture
Episode 3, Jan 31, 12:26 AM
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Welcome to Risk Revolution, a monthly series of the Voices in Validation, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance how they perceive and manage risk.
On this episode, our Risk Revolution team, Lori Richter and Nuala Calnan invite their colleagues Ghada and Vivian to help define Risk Culture, discuss everyone’s role in achieving a culture that embraces and learns from risk, highlighting a need for risk identification, cover some risk communication tools, and broadening the understanding around risk-based decision-making processes. Ghada provides some valuable insights into risk excellence from her experience as a team leader on the Global QRM Center of Excellence at Merck, while Vivian provides a needed regulatory framework from her time as an agent at MHRA.
Links to Risk Revolution Takeaways:
The JVT Special edition on QRM - https://www.ivtnetwork.com/journal-validation-technology/journal-of-validation-technology-3693
Role of Senior Leadership in Quality Risk Management - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-management
Knowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge... http://www.ivtnetwork.com/article/knowledge-currency-managing-risk-novel-framework-unite-quality-risk-management-and-knowledge
Link to the ISPE Cultural Excellence Report - https://ispe.org/news/cultural-excellence-report
PIC/s A Recommended Model for Risk-Based Inspection Planning in the GMP Environment – https://www.picscheme.org/layout/document.php?id=160
PIC/s Assessment of Quality Risk Management Implementation - https://picscheme.org/layout/document.php?id=148
On this episode, our Risk Revolution team, Lori Richter and Nuala Calnan invite their colleagues Ghada and Vivian to help define Risk Culture, discuss everyone’s role in achieving a culture that embraces and learns from risk, highlighting a need for risk identification, cover some risk communication tools, and broadening the understanding around risk-based decision-making processes. Ghada provides some valuable insights into risk excellence from her experience as a team leader on the Global QRM Center of Excellence at Merck, while Vivian provides a needed regulatory framework from her time as an agent at MHRA.
Links to Risk Revolution Takeaways:
The JVT Special edition on QRM - https://www.ivtnetwork.com/journal-validation-technology/journal-of-validation-technology-3693
Role of Senior Leadership in Quality Risk Management - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-management
Knowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge... http://www.ivtnetwork.com/article/knowledge-currency-managing-risk-novel-framework-unite-quality-risk-management-and-knowledge
Link to the ISPE Cultural Excellence Report - https://ispe.org/news/cultural-excellence-report
PIC/s A Recommended Model for Risk-Based Inspection Planning in the GMP Environment – https://www.picscheme.org/layout/document.php?id=160
PIC/s Assessment of Quality Risk Management Implementation - https://picscheme.org/layout/document.php?id=148