The ICH Q9 Quality Risk Management (QRM) guideline has become an accepted standard, facilitating the development and implementation of a systematic risk-based approach to quality management of clinical trials and pharmacovigilance. Industry and regulatory bodies, including the EMA and FDA, have recognized the need and benefits of implementing a risk-based approach to quality management. This web seminar is designed to provide a strong conceptual foundation of the principles of quality risk management with a clear focus on the application of these principles. The course will address applying QRM to support decision-making throughout the clinical trial management and pharmacovigilance process, allocating limited resources effectively to areas of high risk, and preparing the participant to become an active contributor towards risk-based quality management at his/her organization.
- Define Quality Management System (QMS) levels for applicable areas in clinical trials and pharmacovigilance
- Build quality at key points in the process
- Apply QRM principles: Identification and quantification of key risk indicators
- Implement a quality by design approach to overcome shortcomings in quality and compliance
- Leverage existing information to support decision making in resource allocation within clinical trials
- Create a governance model to support mitigation strategies and the overall QMS infrastructure
- Clinical Research, Operations, and Development Professionals
- Medical Affairs Personnel
- Safety and Risk Management/Operations Personnel
- Compliance, Regulatory Affairs, and Clinical Quality Assurance Personnel
Ken Schiff B.A., M.B.A.
Randy Ramin-Wright, M.Sc.
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Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.