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Process Change Assessment

Overview

Course Description

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

Description

Learn about the change control process, the interaction with different elements of the quality system, and the considerations when creating a process change assessment.

Duration: 9 hours

Modality: Group

Participant limit: 15

Download Course Technical Information

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Course Features

Learn about the change control process, the interaction with different elements of the quality system, and the considerations when creating a process change assessment.

Duration: 9 hours

Modality: Group

Participant limit: 15

Download Course Technical Information

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