February 2024 SOCRA Source Journal - Journal - Page 94
SOCRA Quality Management Virtual Conference
JUNE 7 TO 9, 2023 I VIRTUAL
Registration Fees: Member: $415, Non-Member* $490
*includes one year membership
Goal: 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:
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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 12.75 Continuing Education Credits for SOCRA
CE and Nurse CNE.
SOCRA designates this live activity for a maximum of 12.75 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
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SOCRA SOURCE © May 2023