Advanced Auditing for Good Clinical Practice_Corporate

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ICH defines audits as planned and established systematic examinations of trial-related processes and documentation to determine global compliance. An Audit is also an opportunity to prospectively evaluate the systems that drive those processes and generate the date and documentation to be assessed.

Learn the most updated, advanced techniques that international professional auditors employ.

This course will cover the more advanced aspects of Auditing Techniques, utilizing the synthesis of regulatory documents and recent case studies to support a proposed framework of systems with procedures that assure the quality of every aspect of the trial is addressed while proactively assessing regulatory risks. The role of the professional auditor will be discussed and tools to faciliate implementation and application of risk-based procedures for conducting different types of audits of select entities will be introduced.

Interactive exercises and role-playing using real-life audit scenarios and examples will be used to guide participants from audit planning to dissemination of findings and response to regulatory communication.

Focus is on US. FDA regulations, ICH guidelines, HSA Prospectives and selected international standards.

Note: This course is designed for Clinical Professionals with some basic auditing experiences.

 

COURSE OBJECTIVE

  • Review the regulations and guidance that governs clinical research compliance
  • Discuss GCP Auditing as a profession and how it differs from monitoring
  • Determine who gets audited and key factors and metrics for assessing when or why to audit
  • Explore how the FDA trains its inspectors to audit Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs)
  • Apply a quality-systems framework for assessing data and systems
  • Implement data trend analysis to identify regulatory risks
  • Develop practical auditing skills using real-life audit examples
  • Participate in role-play to enhance communication proficiency (Intake and Output)
  • Communicate comprehensive findings with writing exercises and group discussions

 

WHO SHOULD JOIN

  • Clinical Research professionals and associates
  • Clinical Scientist / Basic Scientist
  • Clinical Investigators / Principal Investigators
  • Experienced Clinical Quality Assurance Professionals
  • Project Managers
  • Clinical Study Coordinators
  • GCP-focused Regulatory Affairs Professionals
  • Professionals that had undergone basic clinical training