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Quality Risk Management Overview

Tuesday, September 18, 2018

1:00 PM - 2:00 PM

1:00 PM - 2:00 PM See all dates and Times

http://bit.ly/2NEuRA0


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.
AREAS COVERED
• 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 QRM tools and their application.
LEARNING OBJECTIVES
Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM, explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions. In addition they will be able to identify key QRM terminology and recognize the four (4) key components of Quality Risk Management. Finally they will have a strong understanding of the key concepts associated with the risk management risk tools and their application.
WHO WILL BENEFIT
This course is designed for people tasked with developing, filing, and manufacturing pharmaceutical products especially small molecule oral dosage forms.
• Senior quality managers
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Production supervisors
• Manufacturing engineers
• Production engineers
• Process owners
• Quality engineers
• Quality auditors
• Development professionals
• Senior development managers

For more detail please click on this below link:
http://bit.ly/2NzPg9e


Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882


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