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.
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 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