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


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

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