Program Outline:
Understanding and Meeting Regulatory Requirements and Expectations for Change Control
Optimizing Change Control Program
Planning and the Initiation of a Change Proposal
Evaluation of the Change Proposal - Change Control organizations
Change Control Implementation
Change Control Documentation Requirements
Essential Tools for Establishing a Robust Change Control Program
Developing a Harmonized Change Control Process
Implementation and Verification of the Global Change Control Process
Scope for Your Change Control System
Post Implementation — Monitoring and Maintaining a Change Control Program
Case Study

Implementing Change Control During and After Validation

Workshop

Measuring the Efficacy of Change Control
How to Manage Changes in the Laboratory
Change Control — A Key Element of a Quality System
Risk Management