The objective of this course is to provide students with an understanding of the change control process, interaction with different elements of the quality system and considerations when creating a process change assessment in the medical devices industry.

Throughout the course, students will engage in hands-on learning experiences, applying their knowledge of change control in the medical device industry, ensuring regulatory compliance, maintaining quality standards, and addressing real-world challenges.

At The End Of The Course You Will Be Able To

• Understand the concepts of change control in the medical device industry.
• Understand an overview of the medical device change control and regulatory and quality management system (QMS) compliance.
• Understand the types of changes according to different criteria.
• Learn the elements of the impact assessment in medical device change control process.
  • Change Description
  • Scope of Chance
  • Risk Assessment
  • Validation Assessment
  • Production and Process Assessment
  • Regulatory Assessment

• Experience in a practical way, real-world situations, and examples on change control.

Course Content

1. Regulatory Requirements
2. Definition of Change
3. Change Workflow
4. Change Types
5. The Impact Assessment
   • Change Description
   • Scope of Chance
   • Risk Assessment
   • Validation Assessment
   • Production and Process Assessment
   • Regulatory Assessment