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 speaker will address data integrity and technology controls from a sponsor perspective, emphasizing sponsor-site tie-ins and pertinent regulations. Additional sessions will cover the fundamentals of building quality management programs, inspection readiness, and various quality assurance/control strategies. This educational offering includes both basic and advanced material, with a focus on capturing the essence of quality assurance.
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:
- Discuss the importance of quality management systems (QMS) in clinical research
- Review the key steps and elements in Risk Management and Quality Systems
- Discuss best practices in assessing and mitigating risk in clinical trial project management
- Discuss risk assessments, monitoring plan creation, and monitor training
- Discuss how to develop and implement a Quality Assurance (QA) Program for Investigator-Initiated Trials (IITs)
- Review the planning and implementation of real life examples of quality initiatives
- Review the essentials of conducting an audit/inspection ready study
- Review best strategies on audit/inspection close out processes including 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
