Program Description

Quality Management Conference 

Goal: The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals responsible for the activities at the research site or institution. The purpose of this workshop is to assist research professionals in understanding, developing and implementing quality management systems (QMS) in the conduct of clinical trials.  This conference provides attendees with new information, tools, and real life examples to help participants navigate the components of quality management in clinical research - quality planning, quality control, quality assurance, and quality improvement.

Objective: The goal will be accomplished through lecture and practical application facilitated by clinical research professionals. Information will be presented and discussed regarding the development and implementation of quality management systems in the conduct of clinical trials according to FDA Regulations and International Council on Harmonisation (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