Medical Device Change Control Online Course & Certificate

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.

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

No prerequisites are required.

 Students will be assigned 5 homework assignments, and 1 final exam. 

INTRODUCTION

• What is Change Control
• Change Control process

CHANGE CONTROL PROCEDURE

• Identification
• Effective Date
• Responsibility
• Revision Level
• Validation
• Communication
• Updating Documentation Documentation
• Distribution
• Remedial Actions
• Regulatory Submissions
• Business Factors

QUALITY ASSURANCE REVIEW

CHANGES UNDER PREMARKET NOTIFICATION

• Regulatory Background
• Premarket Notification Decisions
• Quality System Control

EXAMPLES

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