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Overview

This clinical trial audit course is designed to provide training on methods and approaches to plan, conduct and report on different types of audits with examples of practical implementation and discussion of challenges. Recent trends and updates in clinical trial legislation and guidance, increased use of electronic systems in clinical trials as well as implementation of risk management principles are imbedded. The course is a combination of presentations, panel discussions and exercises by an experienced team of auditors and EMA and inspector representatives.

What you will learn

  • Regulatory framework EU and ICH
  • Quality management, defining quality
  • Risk-based approach to audit and inspection planning and conduct
  • Trial system and vendor audit in practice
  • System audits
  • Communication of audit findings
  • Inspections by European and other authorities
  • Who should attend?

    This course is designed to provide practical training for auditors and regulatory authority inspectors, who are faced with the challenging task of auditing or inspecting clinical trials and related systems. It will also be of interest to those to clinical trial coordinators in a quality role at health institutions. The content may also benefit quality managers performing self-inspections.

    Learning objectives

    At the conclusion of this course, participants should be able to:

  • Apply common audit methodology principles to clinical trials in Europe and other countries
  • Conduct and report on trial specific and system audits
  • Understand requirements for inspections
  • Apply a risk based approach for the planning and conduct of audits
  • Program Committee

    • Fergus  Sweeney, PhD
      Fergus Sweeney, PhD Head of Inspections and Human Medicines Pharmacovigilance (Division)
      European Medicines Agency, European Union, United Kingdom
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