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.
Areas Covered in the Session :
Overview of Change Control Regulatory Requirements
What is Change Control?/Why Change Control?
Types of Changes Subject to Change Control
Like for Like
Specification changes
Facility Changes
Equipment Changes
Emergency Changes
Change Control Proposal
Proper documentation
Elements to be included
Change Assessment (Risk, Impact) and Approval to Execute
Impact to products
Impact to facility
Impact to Regulatory Filings
Change Control Board Development
Areas of Responsibilities for Board Members
Establishing Action Items
Establishing Deadlines
Final Implementation of Change
How to close out a change
Effectiveness of the change
Change Control Documentation
Hard copy systems
Electronic systems
Who Should Attend:
Quality Assurance Teams
Quality Control Teams
Manufacturing Teams
Production Teams
Regulatory Teams
Management Teams