Change Control

In this course, the student will learn regulatory requirements for change control. We discuss topics such as:

• What is a change?
• FDA regulatory requirements
• EU regulatory requirements
• Applications
• FDA 483's and warning letters
• The change control process
• Effective date
• Responsibilities
• Validation / revalidation
• Documentation
• Regulatory submissions
• Implementation
• Setting up a change control system

Tthe course allows for plenty of discussion and questions.