Quality Risk Management Overview: Key Concepts, Principles and Applications

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 just a tool like FMEA analysis. This training will explain the important concepts associated with a QRM approach.

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 understand how the QRM process is used to make decisions. In addition they will be able to identify key QRMterminology 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 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. This includes individuals that have responsibilities for formulation development, scale-up, filing, and commercial manufacture of dosage forms as well as maintaining the high quality of those products. Following personnel will benefit from the course:

• 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

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