OVERVIEW

Change Control - GMP Requirements and FDA Enforcement is organized by The Center for Professional Innovation & Education (CfPIE), Inc. and will be held from Nov 17 - 19, 2026.

Description:
Change Control is arguably the most critical quality system for safeguarding patient safety and product quality. Although specific steps vary from firm to firm, there are a few standard elements and best practices that are essential for a robust, sustainable change control program. Many firms struggle to complete change controls in a timely manner, and spend incalculable time, effort, and rework trying to keep up. This course provides a simple, high-level process, along with best practices and techniques for sticking to it in a timely manner, while maintaining compliance, and safe and effective products for patients.

The course includes key definitions, regulatory requirements, importance, and basic change control process overview, including key roles and responsibilities. It also provides specific do’s and don’ts for all key roles and steps in the change control process, including requesting changes, assessing risk and classifying changes, action planning and coordination, assessing impact, designing effectiveness checks, and writing results and justifying conclusions. It also includes how to manage change controls, and write clear, logical reports that withstand regulatory scrutiny.

This interactive course includes audience questions and polling, activities and exercises to help participants apply and retain the knowledge.

Learning Objectives:
At the end of the course, attendees will be able to:

Explain why Change Control (CC) is so critical to Biopharm/device companies and the patients they serve.
Cite key GMP requirements and FDA enforcement examples for CC.
Explain what CC is and its elements at a high level, including the difference between major and minor changes.
Identify each role in the CC process and the responsibilities of each.
List Do’s and Don’ts for Change Owners, including writing the change request.
List key considerations for a subject matter expert (SME) impact assessment.
Give examples of Pre-, Post-, and Implementation actions.
Develop targeted change plans, including actions, action owners, and due dates.
Design and conduct adequate effective checks to verify that the change was/was not effective, and develop remediation actions if the change is not effective.
Write change control sections clearly and concisely, including change request, SME assessment, action plans, results and conclusions, and effectiveness checks.

The goal is to ensure all attendees walk away with practical, actionable best practices and foundational knowledge that they can bring back to their firms, whether as simple practitioners or approvers, or as change control champions and change agents to help improve their change control programs, improve completion times, and ensure consistency across change control participants and stakeholders.