Successful Change Control Management

🎤 Danielle DeLucy | 📅 May 30, 2024 | 🕒 11 AM Eastern Time US

Description:

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

Medical Device FDA