Internal Auditor Training for Medical Device Manufacturers E-Learning with WMDO

This course introduces the theoretical segment of WMDO’s internal audit training program and describes how to develop an effective and useful Internal Audit Program (IAP).

The course demonstrates how to perform internal audits for medical device manufacturers or third party quality systems, including related processes. It also takes into account the requirements of ISO 13485, European Medical Device Directives, and the affiliated sections 21CFR820.

This course covers the following topics:

• Definition and background of internal auditing
• Regulatory and statutory frameworks of internal auditing
• The internal auditing process and its function as part of a management system
• A detailed outline of audit planning, preparation, conduct, and follow-up
• Logical links within the quality system according to the GHTF subsystem structure
• An outline of instructions and requirements on how to become an internal auditor, including training and soft skill development
• Practical instructions for maintaining excellence and efficiency throughout activities involving internal auditing

To enroll and purchase this course, please visit the WMDO website at: http://www.wmdo.org/SGS.aspx

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

• Comprehend and apply the appropriate statutory and regulatory requirements in the setup, management, and execution of internal auditing systems
• Prepare and implement an efficient IAP
• Perform internal audits within the framework of an organization’s internal auditor qualification program