Change Control - GMP Requirements and FDA Enforcement

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Course Director

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Course Fee

$2150.00 Regular Registration

$1950.00 Early Bird Pricing (Register 30 Days in Advance)

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Course 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.

Who Should Attend

This comprehensive 15 hour course will be valuable to all personnel involved in the change control process in any GMP environment, including Manufacturing, Quality, Supply Chain, and Facilities and Engineering employees. It will benefit individual contributors, subject matter experts, area managers, and QA personnel who author, coordinate, contribute to, assess risk for, and/or approve change controls.

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  • Learning Objectives

    TAt 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.

  • Agenda


    Welcome

    • General overview and purpose of change control
    • Key definitions
    • Why Change Control is so important from regulatory and patient perspectives

    Regulatory Requirements

    • cGMP (FDA, EMA)
    • Guidance documents (e.g. ICH Q10)

    Roles & Responsibilities 

    • Change owner
    • Change Review Board
    • SMEs
    • Action owners
    • Approvers
    • Quality

    Change Control Process

    • Request
    • Assessment
    • Plan
    • Pre-implementation actions
    • Implementation actions
    • Post-implementation actions/Effectiveness checks
    • Closure

    Do’s and Don’ts

    • Change Owners
    • Change Review Board
    • SMEs
    • Action Owners
    • Approvers
    • Quality

    Deep Dive on Implementation Actions

    • Pre-Implementation
    • Implementation
    • Post-Implementation

    You Try It!

    • Case Study provided for all to read
    • Divide into teams
    • Assign roles for each team
    • Each role goes to breakout room to discuss questions provided
    • Discuss results as a class

    Summary/Q&A/Wrap-Up

    • Highlight key points from session
    • Q&A
    • Encourage attendees to be change agents, and apply learning

  • Testimonials

    "This course was thorough and had a good mix of material presentation and activities. It was well done. It was great to discuss a concept and then put it into practice."

    Kristen O., Sr. Quality Systems Specialist, Forge Biologics


    "Significantly better than courses from other providers. Other courses were just too general and didn't teach how to apply the information within your own company. They also weren't very interactive. The breakouts were useful; it was very interactive; the instructor clearly knew his stuff and knew how to get people thinking and engaged in the course."

    Donna K., Assistant Director, QA Systems Mgmt., Daiichi Sankyo


Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.