This webinar will provide an overview of regulatory requirements for change control. It will focus on changes to equipment, facilities, materials/components, test methods, suppliers, specifications, etc.
This webinar will help attendees understand the fundamental change control steps and skill sets. 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.
Why Should You Attend:
Change Control is a critical element of the Quality Management System. Changes to processes, equipment, facilities, materials/components, suppliers, test methods, specifications, etc; must be properly managed to prevent unintended consequences, and to comply with regulatory requirements. Improper change control can result in significant compliance and product quality problems.This webinar will help attendees understand the fundamental change control steps and skill sets. 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 Webinar:
- Overview of Change Control Regulatory Requirements
- What is Change Control?/Why Change Control?
- Types of Changes Subject to Change Control
- Change Proposal
- Change Assessment (Risk, Impact)
- Approval to Execute Change
- Executing the Change
- Final Implementation of Change
- Change Control Documentation
Who Will Benefit:
- Regulatory Affairs
- Qc/QA Personnel
- R&D and Engineering Staff
- Change Control Reviewers/Approvers (e.g. Validation, Regulatory Affairs, Quality Assurance)
- Quality Assurance Management responsible for Change Control Systems
- Supply Chain Managers
Course Provider
Andrew Campbell,
