Description
This Primer Module for the Audit Program Management course will introduce entry-level concepts of auditing and quality management systems outlined for the basic Audit Program Manager Competency Requirements outlined within ISO 19011:2018 Guidelines for auditing management systems.
An emphasis is placed on the medical device industry and will incorporate elements of ISO 13485:2016, and 21 CFR 820.
A combination of text, and video is provided to teach in a manner that captures multiple learning styles, and the suggested practical exercises will generate immediate value for your Quality Management System. This module is designed for those who are new to the industry that need an introduction to program management under ISO 19011:2018. This course will set the groundwork for up-and-coming program managers that may not have previous auditing experience.
Learning Outcomes
After successful completion of this Primer Module for Audit Program Management, students should have an introductory exposure to the outlined elements and areas of knowledge for Audit Program Manager competence in accordance with Clause 5.4.2 Competence of individual(s) managing audit programme of ISO 19011:2018.
- audit principles, methods, and processes;
- management system standards, other relevant standards, and reference/guidance documents;
- information regarding being an auditee and context in relation to developing an audit program;
- applicable statutory and regulatory requirements and other requirements relevant to the business activities of the auditees.
Prerequisites
This primer course has no pre-requisite.
This primer module provides entry-level information to better understand the process of Audit Program Management.
Primary Instructor
Matthew Walker is the primary instructor for this Audit Program Management Primer Module. He has been with Medical Device Academy since 2016. He has worked in Quality Management Systems and Regulatory Affairs. A RAPS member since 2019, Matthew is a Medical/Technical Writer and qualified Lead Auditor. He is currently focusing on training and development with a concentration on Auditing, Human Factors Engineering, Risk Management and Cybersecurity.
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