August 2024 SOCRA Source Journal - Journal - Page 91
SOCRA Quality Management Conference
JUNE 26 TO 28, 2024 | VIRTUAL
OCTOBER 24 & 25, 2024 | CHICAGO, IL
In-person Workshop registration fee: $645 (Non-member $720 - includes one year’s membership)
Virtual Workshop registration fee: $415 (Non-member $490 - includes one year’s membership)
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
SOCRA designates this educational activity for a maximum of 12.25 (in-person) or 9.75 (virtual)
Continuing Education Credits for SOCRA CE and Nurse CNE.
SOCRA designates this live activity for a maximum of 12.25 (in-person) or 9.75 (virtual)
AMA PRA Category 1 Credit(s)™.
Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for
Continuing Medical Education to provide continuing medical education for physicians.
CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education
by the American Nurses Credentialing Center's Commission on Accreditation.
SOCRA Course Series: 120
SOCRA SOURCE © May 2024
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