Online CourseOnline Course Medical Device Certificate ElectiveMedical Device Certificate Elective

Medical Devices: Compliance & Audits [5.0 RAC]

5.0 RAC Credits Member: $545.00 Nonmember: $745.00
Medical Devices: Compliance & Audits [5.0 RAC]
Auditing is a requirement in the world of medical devices. There are many types of audits, including, but not limited to, first-party, internal, second-party, supplier, external and agency audits. Regardless of the audit’s nature and scope, the purpose is basically the same—to assess compliance with the Quality Management System (QMS) requirements. Typical audit outcomes require manufacturers to take some sort of action to come into compliance with standards or regulations and make improvements to quality management systems.

A quality system audit is one of the most important good manufacturing practice (GMP) requirements. The process of auditing medical device quality systems is similar to quality system audits in other industries, but with a distinct difference. Whereas other quality systems may focus more on quality as a component of customer satisfaction, a medical device audit focuses on ensuring compliance with regulatory agency requirements (e.g., FDA, Health Canada, EMA, TGA, CFDA, etc.) or other applicable regulations, with the goal of assuring patient safety and product effectiveness. A quality system audit is performed to determine whether the company’s QMS meets regulatory requirements and ensures products meet specifications and customer expectations.

Regardless of the nature and scope of an audit, any finding should be addressed with corrective and preventive actions (CAPAs) to help drive compliance to standards and continuous improvement(s). Audits often identify areas that need improvement and offer valuable insight into the proper functioning of a compliant Quality System.

At a Glance
  • Target Audience: This course is designed for quality and regulatory professionals with little or no previous auditing experience and individuals who need to broaden their knowledge of the audit process.
  • Learning Level: Basic
  • Total Length of Course: 5 Hours
  • RAC Points: 5

Learning Objectives

Upon completion of this course, participants should be able to:
  • Describe FDA’s medical device compliance requirements and the requirements of other major regulatory bodies around the world.
  • Prepare and conduct an audit and an audit close-out meeting.
  • Develop the records required to document audit activities.
  • Describe auditing techniques, tips and methods employed by skilled auditors to identify underlying issues and assure compliance.

Lesson Titles
  • Lesson 1: Medical Device Compliance
  • Lesson 2: Auditing in the US
  • Lesson 3: Auditing in the EU
  • Lesson 4: Auditing in Canada
  • Lesson 5: Auditing in the Rest of World
  • Lesson 6: Auditing Techniques and Tools

Enrollment Period: 12 months
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