Course Description

Change control is a systematic approach to managing all changes made to a product or system in a controlled and coordinated manner. Change control activities and procedures apply to: design; components, including software; labeling and packaging; device manufacturing processes; production equipment; manufacturing materials; and all associated documentation such as quality system procedures, standard operating procedures, quality acceptance procedures and data forms, and product-specific documentation. Change control should also be applied to any production aids such as labeled photographs and models or samples of assemblies and finished devices.

“Medical Device Change Control” is a course that provides students with a comprehensive overview of how to effectively identify, qualify, manage, implement, and document changes for FDA regulated medical devices and pharmaceutical products.

Course Outcome

After completing Medical Device Change Control, students will be equipped with a basic understanding of the following:

• what is change control
• how to manage change control
• considerations for change control
• how to document change

Recommended Prerequisites

No prerequisites are required.

Assessment

There will be 5 homework assignments and 1 final exam.

Syllabus

Course Delivery

This course is Instructor-led and delivered through our award-winning online Learning Management System.

Education Credit

This course has 20 contact hours and can be used for 2 Continuing Education Units (CEUs).