Training Doyens

OVERVIEW After attending this course you will be able to: Recognize the purpose and value of Quality Risk Management (QRM) , as well as how it applies to your job. Explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions. Identify key QRM terminology. Recognize the four (4) key components of Quality Risk Management. Identify examples of Quality Risk Management tools and their application. WHY SHOULD YOU ATTEND Per ICH Q10, quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. However integrating the principles of QRM into our quality processes is complex especially in a pharmaceutical organization.  There is much confusion on how to define risk and individuals often think of quality risk management as j...

OVERVIEW After attending this course the audience will Recognize the purpose and value of Quality Risk Management (QRM) , as well as how it applies to your job. Explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions. Identify key QRM terminology. Recognize the four (4) key components of Quality Risk Management Identify examples of Quality Risk Management tools and their application. WHY SHOULD YOU ATTEND Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and Controlling potential risks to quality. However integrating the principles of QRM into our quality processes is complex especially in a pharmaceutical organization. There is much confusion on how to define risk and individuals often think of quality risk management as just a tool like FMEA analysis verse...