This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed. This course will provide attendees with the proper tools and information to build a robust change control quality system that will withstand the scrutiny of a FDA or Regulatory Inspection.
Learning Objectives:
- Identify what constitutes a change
- Learn how to properly categorize a change
- Demonstrate how to write/execute a Change control proposal, assessment and close out
- Discuss the Establishment of a change control board
