Course Description
This course provides an in-depth examination of the principles, processes, andpractices required to ensure compliance, quality, and consistency in clinical trials. It emphasizes the role of Standard Operating Procedures (SOPs) as a foundation for operational excellence and regulatory adherence across the clinical, laboratory, and manufacturing settings.
Participants will learn how to design, implement, and manage SOPs, apply quality assurance methodologies, and maintain compliance with international regulations such as ICH-GCP, FDA, EMA, and Health Canada guidelines. The course also explores quality management systems (QMS), auditing practices, documentation standards, and strategies to prepare for regulatory inspections.
Through case studies and applied exercises, learners will gain a solid understanding of how to ensure data integrity, subject safety, and organizational accountability. This course prepares participants to build, sustain, and oversee effective compliance frameworks within the dynamic landscape of clinical research and product development.Course Summary
Upcoming Courses
Learning Objectives
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Understand the role of SOPs in ensuring consistency and compliance
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Apply quality assurance principles to trial conduct
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Identify key regulatory guidelines and compliance requirements
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Learn best practices for Case Report Forms (CRFs) and documentation
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Recognize the impact of audits and inspections
Who Should Attend
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QA/QC professionals in clinical research
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Clinical Research Associates and Coordinators
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Regulatory Affairs staff
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Clinical Operations team members
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Professionals preparing for audits/inspections
Course Outline
Module 1
Introduction to SOPs in Clinical Trials
Module 2
Quality Assurance Principles and Quality Control Tools
Module 3
Regulatory Requirements: ICH, FDA, Health Canada, EMA
Module 4
Documentation Standards and CRF Management
Module 5
Preparing for Audits and Inspections
Module 6
Case Examples of Quality Failures and Lessons Learned
Interactive Activities
- •SOP drafting exercise in small groups
- •CRF completion and error-checking workshop
- •Mock audit scenario with group role-play
