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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Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-12-015-L01-P. Released: 2/12.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.