Quality Risk Management Training

Overview:

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 verses an overall QRM approach. This training will explain the important concepts associated with a QRM approach

Why you should Attend:

• 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

Areas Covered in the Session:

• 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

Who Will Benefit:

This course is designed for people tasked with developing, filing, and manufacturing pharmaceutical products. 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. In addition, other related industries will benefit. The 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
• Risk Management
• Quality Assurance /Control 
• Project Engineers and Managers, Commissioning, Validation, Engineering and Service Providers
• Manufacturing Operations and Facilities Professionals