Course Description

Clinical Audits: Fundamentals of Auditing Medical Device Clinical Investigations

Course Description:

This course reviews the fundamentals of the auditing process for medical device clinical investigations, including the various types of audits and their purpose, scope, management, and execution.

The content of this course is based on:

  • ISO 14155: 2011: Good Clinical Practice for Medical Devices
  • ICH-E6: Good Clinical Practice for Pharmaceutical Products
  • 21CRF 50 Protection of Human Subjects
  • 21CFR 54 Financial Disclosure by Clinical Investigators
  • 21CFR 56 Institutional Review Boards
  • 21CFR 812 Investigational Device Exemptions
  • 93/42/EEC Medical Device Directive
  • 90/385/EEC Active Implantable Medical Device Directive

Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Determine when clinical investigations of medical devices must be audited
  • Identify the areas, departments, teams, and facilities that should be covered by the clinical investigation audit program
  • Understand the basic elements of an effective audit from planning to closure
  • Verify the applicable regulatory standards and decide which ones to apply to the auditing plan

Who Should Enroll:

Clinical project managers, clinical research auditors, and quality assurance and regulatory managers interested in establishing an auditing system for clinical investigations or in preparing clinical investigation audits are all encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

The following material is required:

  • Extensive experience with medical device good clinical practice activities
  • A minimum of five years (preferably) in an active Clinical Research Associate or project management position in the medical device field
  • Expert knowledge of the medical device regulatory requirements outlined in the course description above (applies to experienced auditing professionals from the pharmaceutical industry only)

Subject Matter Expert:
Alodia Ruiz

36 min

Related resources:

Case studies:

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