Thursday September 2, 2010
Preparing & Implementing an Effective
Change Control System
March 23-24, 2010 - Philadelphia, USA

A Two Day Comprehensive & Interactive Course with Workshops and Case Study Discussion On:

  • Regulatory Requirements and Criteria for Change Control
  • Preparing for the Change Control Process
  • Designing a Harmonized, Global Change Management System
  • ICH Q9 Risk Assessment and Change Management
  • Conducting a Gap Analysis of the Change Control Process
  • Deciding to Automate or Centralize the Change Control System
  • Following Changes During Product Development
  • Controlling Changes to Facilities
  • Managing Changes in the Laboratory
  • Coordinating Changes with Contract Manufacturing and Packaging Facilities
  • Handling Customer-Initiated, Emergency and Temporary Changes
  • Documenting Change Justifications
  • Post Change Monitoring Requirements and Strategies
  • Follow up and Closure of Implemented Changes
  • Using Metrics to Measure and Assess Changes
  • Coordinating Changes Across Multi-Departmental Boundaries

Interactive Workshop and Case Study Discussion Sessions:

  • Review of current FDA 483s related to Change Control
  • How to Prepare for the Change Control Process
  • Creating Change Proposals and Completing Change Requests
  • Organizing Change Documentation, Procedures and Forms
  • Reviewing Change Control Responsibilities within Quality Agreements
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