Auditing for Medical Devices

This online course provides you with the basic competencies required to effectively perform the auditor’s assigned responsibilities by defining audits, explaining why audits are carried out, discussing the types and levels of audits and discussing what is required for preparing to audit medical devices.

*NOTE* This course is not designed to prepare companies to be audited by regulatory authorities.

Course Modules/Learning Objectives

  • Module 1: Auditing and Audit Preparation
    • Define audit and explain why audits are carried out.
    • Discuss types and levels of audits.
    • Discuss preparation for an audit.
  • Module 2: Attributes of a Good Auditor
    • Explore auditing fundamentals (auditory traits and skills).
    • Describe strategies for asking questions.
    • Describe good listening skills.
    • Review the importance of body language on the audit process.
  • Module 3: Steps and Activities for a Successful Audit
    • Review the audit timetable.
    • Provide guidelines for conducting the audit.
    • Discuss the importance of records and note taking.
    • Provide auditing tips and resources for auditors.
  • Review problems.
  • Module 4: Post-audit Activities and Follow-up
    • Provide guidance for exit meeting preparation.
    • Explore managing your findings.
    • Explore attributes and considerations of a good report.
    • Review follow-up activities and problem solving tools.
  • Module 5: Medical Device Regulation Requirements
    • Review industry organizations.
    • Review of global medical device regulation requirements.
  • Module 6: Computerized Systems and Validation
    • Review U.S. And E.U. Regulations relevant to computerized systems compliance.
    • Explain the concept of GxP risk.
    • Provide an overview of the general requirements of computerized system compliance and validation.
    • Define audit and explain why audits are carried out.
    • Explain the scope and purpose of GAMP® 5.
    • Explain good supplier practice.
    • Discuss the responsibility of a regulated company.
    • Illustrate the supplier assessment process.
    • Review GAMP® 5 approach to testing.


  • Individuals with two or three years of direct experience working with GMP guidelines who want to develop additional expertise in GMP Auditing.

  • New auditors or individuals wanting to become auditors.

  • Professionals who are responsible for conducting internal or vendor GMP audits specifically for medical devices.

  • Suppliers and others who are audited, such as quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, and and all levels of management.

  • Component and contract manufacturers.

  • Contract Testing Laboratories.

  • Re-packagers, re-labelers and specification developers.

  • Participants who work in the medical device industry and who currently are or wish to sell their product in the US, Europe and other parts of the world will profit attending this course. This includes professionals responsible for understanding and interpreting global regulations within their companies, in areas such as Regulatory Affairs, Compliance, Research and Development, Quality Assurance, Quality Control, Clinical Research.

Jeri Weigand, is currently a clinical quality auditor, working for the Medtronic Clinical Research Institute, Medtronic, Inc. in Fridley, Minnesota. Prior to this role, she was a corporate quality system auditor at Medtronic, auditing internal and external manufacturing and lab sites in the US and globally. She previously spent thirty years working for 3M Pharmaceuticals in various capacities, most recently, working as an auditor for 3M Pharmaceuticals in St. Paul, MN.




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