Program Description
Quality Management Conference
Goal: The Society of Clinical Research Associates (SOCRA) recognizes the ongoing need for education among Clinical Research Professionals responsible for activities at research sites or institutions. This workshop is designed to help these professionals understand, develop, and implement quality management systems (QMS) in the conduct of clinical trials. The conference equips participants with new insights, practical tools, and real-life examples to skillfully navigate the components of quality management—quality planning, control, assurance, and improvement.
The keynote, jointly led by a former FDA Foreign Expert and a noncompliance expert, will share real-world insights from Quality Systems inspections resulting in major findings and enforcement actions. Attendees will examine common pitfalls and inadequate CAPA responses, gaining strategies to build stronger, more effective corrective actions. The session will provide practical tools to fortify Quality Systems and prepare teams for successful regulatory inspections.
Objective: Led by seasoned clinical research professionals with sponsor-level and site-level expertise, this event combines lectures and hands-on applications, delivering vital information on developing and implementing effective quality management systems in line with FDA Regulations and ICH guidance.
Learning Objectives: Upon completion of this (full) course the attendee should be able to:
- Outline how enforcement cases inform quality management practices in clinical research.
- Highlight key features of ICH GCP (R3), focusing on quality.
- Discuss the importance of quality management systems (QMS) in clinical research.
- Discuss how to develop and implement a Quality Management System (sponsor and site level).
- Review the planning and implementation of real-life examples of quality initiatives.
- Demonstrate how to implement self-monitoring/tracking within a Comprehensive Cancer Center.
- Discuss best practices in assessing and mitigating risk in clinical trial project management.
- Review the essentials of conducting an audit/inspection-ready study.
- Review the best strategies in audit/inspection close out processes including root cause analysis, CAPA development, and implementation.
- Discuss the management of serious breaches and non-compliance.
- Outline the impact of system non-compliance, sanctions, and fraud.
- Outline the top QA and QC trends to elucidate ideal training and educational needs.