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