Fundamentals of Risk Management in Clinical Research 2018

Topics

• Develop relevant metrics as quality and performance indicators for Risk-Based Quality Management (RBQM) systems
• Describe principles of Quality by Design (QbD) and new regulatory requirement for Risk-based monitoring
• Perform Cause-Effect Anaylysis for identified risks and develop mitigation strategy
• Identify and manage risks of clinical trials
• Develop effective Corrective Action Preventive Action (CAPA) Plans
• Review recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs

Who should Attend

• Clinical Research Associates
• Clinical Quality and Compliance Professionals
• Medical Monitors
• Project Managers