Introduction

Welcome

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.

This primer will introduce the elements Quality Management and Regulatory Affairs of medical devices that an Audit Program would manage. This course is not designed to turn you into a program manager or to solely build your own audit program. It will certainly help and can add value, but that is the purpose of the Audit Program Manager course.

The short video below will walk you through navigating our content so that you can focus on learning the content and not “how” to learn it.

Course Content

This course will be presented in text and video format. This primer module is made up of 3 Lessons, the ‘Introduction‘ Lesson that you are in now, ‘Anatomy of an Audit‘, and ‘Standards, Guidance Documents, and Regulations‘. Each lesson is comprised of multiple topics and there are progress check mini-quizzes, and optional exercises scattered throughout.

Quizzes and Progress Checks

The progress checks are designed to provide a snapshot of your knowledge retention of the course material. They are graded, but retakes are allowed. The intention is either to identify areas that need to be re-reviewed, or confirm retention of the course materials. These checks are also an open resource. That means, notes, standards, websites, etc. Everything… Literally EVERYTHING.

The medical device industry is massive and it is an unrealistic expectation for everyone to have everything memorized. What might be the best lesson out of this entire primer is not to remember things but to remember how to find the information you are looking for. Memorizing the principles of auditing may not be the best use of your time for the value that it adds to your Quality Management System. Learning that principles of auditing can be identified in a sub-clause of ISO 19011:2018 may be a much more useful skill.

So, if you don’t know the answer to a question off of the top of your head, find it. That will turn a progress check into a value-added learning exercise .

Additional resources are provided. This course will feature download links and URLs for helpful websites. Do not be afraid to steal these links and bookmark the pages. They are here to help and are publicly available. Medical Device Academy does not own the ‘e-CFR’, but we use those regulations almost every day and knowing how exactly to go straight to them is tremendously helpful to us, and hopefully to you as well.

Some of the optional exercises are completed on downloadable Microsoft Word Documents. The documents contain signature lines, and purpose/objective statements. This is so that if you decide the documentation will add value to your quality system you can use it!

The same sentiment is given for the Certificate given to everyone who passes the final exam. This certificate is a record that provides demonstratable object evidence of training and education on a specific topic. Keep it, add it to your personnel file and use it to show how your quality system is meeting its training and competency of personnel requirements.

This course is provided through Learndash. As a learning Management System, your progression through the learning materials is tracked. Part of this progression includes user input from students like you. Be sure when you progress through a topic to click on the ‘Mark Complete’ button of that page in order to take credit for the work you have put in!

This is a serious industry, but we also try to foster a safe learning environment for self-improvement. You are simultaneously tasked with learning a new topic on a Learning Management System (Learndash) that you may not be familiar with. It is possible to get lost or turned around navigating the system. Fortunately, it is easy to get your bearings back. On the left of each page, there is a dropdown menu that shows the course contents. You should be able to navigate to any of the course pages from there!

This sounds like your teaching me Learndash?????

A note from the instructor:

I know this has been a lot of specific information on how to use Learndash and not a lot about Audit Program Management, but there is a reason for that. We want you to be successful. This is an introductory course, but in time we want you to be a leader in this field. This is the medical device industry and even competitors that are mortal enemies are still dealing with real devices that are used to help real people. We want everyone to be successful and a leader for change because someday any one of us might be a patient for any one of the devices that we work with.

Better industry leaders make for better, safer, treatments and devices. For that reason we want everyone to be successful. We want everyone to be a driving force behind the good in this industry. That starts with lending a helping hand to everyone, even those just dipping their toes into this career field. I don’t care if you hire someone else to do your 510(k), or your Internal Audit, I want you to do well, I want you to be successful, and I want this course to help add value to this small part of that journey.

-Matthew C. Walker