This web training session is designed to help attendees understand the fundamental change control steps and processes. The expert trainer will focus on change proposals, assessments, execution and final implementation of a change control quality system. 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.

During this course, the speaker will explain the regulatory basis for change controls, the steps in designing a change control system, and the types of documents or processes that are subject to change control. After completion of this course, you will be able to implement immediate steps in executing a change control form.

AREA COVERED

• 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

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

WHO WILL BENEFIT?

• Pharmaceutical professionals involved in the manufacture of products
• All levels of management
• Quality professionals
• Compliance Officials
• Quality Assurance Personnel
• Regulatory Affairs
• R&D and Engineering Staff
• Change Control Reviewers/Approvers (e.g. Validation, Regulatory Affairs, Quality Assurance)
• Supply Chain Managers