Change Control and Regulatory Impact Assessment
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Speaker : MEREDITH CRABTREE
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When : Wednesday, September 10, 2025
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Time : 01 : 00 PM EST
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Meredith Crabtree has over 30 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting and is a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.
Change is an inevitable part of any regulated industry. However, without a structured approach to managing changes, organizations may face compliance violations, product failures, and reputational damage. Change control is a formalized process that ensures all modifications—whether in materials, equipment, processes, or documentation—are reviewed, assessed, and implemented in compliance with regulatory requirements.
This training will provide participants with a comprehensive understanding of change control and regulatory impact assessment in FDA-regulated industries, such as pharmaceuticals, medical devices, and biotechnology. Attendees will learn how to establish a structured change control system, implement risk-based regulatory impact assessments, and align practices with FDA and ISO standards.
Key discussion areas include:
- Fundamental principles of change control and why it’s essential in regulatory environments
- Developing a change control system with clear roles, documentation, and approval workflows
- Conducting regulatory impact assessments to evaluate compliance risks
- Aligning change management practices with FDA 21 CFR Part 820 and ISO standards
- Documentation and record-keeping best practices
- Real-world case studies on successful change control implementation
By the end of this session, participants will have the tools to minimize compliance risks, streamline operational changes, and foster a culture of continuous improvement and regulatory adherence.
Areas Covered
- Introduction to Change Control:
- Definition and importance of change control in regulated industries.
- Overview of common types of changes (process, equipment, materials). - Framework for Change Control Systems:
- Elements of an effective change control system (documentation, approval processes, communication).
- Roles and responsibilities within the change control process. - Regulatory Impact Assessment Process:
- Steps to conduct a regulatory impact assessment.
- Tools and methodologies for evaluating compliance risks associated with changes. - Alignment with FDA and ISO Standards:
- Key FDA and ISO regulations relevant to change control.
- Best practices for ensuring compliance with these standards during change management. - Documentation and Record-Keeping:
- Importance of documentation in change control.
- Best practices for maintaining records and ensuring traceability of changes. - Case Studies and Lessons Learned:
- Real-world examples of change control implementations and regulatory assessments.
- Discuss the challenges faced and solutions implemented in different scenarios. - Continuous Improvement and Culture of Compliance:
- Strategies for fostering a proactive culture of compliance within organizations.
- Techniques for encouraging employee engagement in the change control process.
Who Should Attend
- Quality Assurance (QA) Managers
- Regulatory Affairs Specialists
- Compliance Officers
- Validation Engineers
- Production Managers
- Process Improvement Specialists
- Research and Development (R&D) Managers
- Change Control Coordinators
- Operations Managers
- Document Control Specialists
Why Should You Attend
Regulatory non-compliance due to poor change control can lead to serious consequences, including FDA warning letters, product recalls, and even shutdowns. If your organization lacks a structured change management process, you risk costly delays, non-conforming products, and operational inefficiencies.
This training provides critical insights into creating a structured and effective change control system that ensures regulatory compliance and minimizes risk. Participants will learn to evaluate the regulatory impact of proposed changes, identify compliance risks, and implement necessary mitigation strategies. The session will also cover documentation best practices, aligning processes with FDA and ISO standards, and fostering a culture of compliance.
Join us to ensure your organization’s change control process is proactive, efficient, and compliant with industry regulations.
Topic Background
In regulated industries, managing changes to processes, equipment, or materials is critical to ensuring compliance and maintaining product quality. Effective change control systems not only help organizations avoid compliance issues but also streamline operations and enhance overall efficiency. This training focuses on implementing robust change control processes, conducting thorough regulatory impact assessments, and aligning change management practices with FDA and ISO standards. Participants will learn best practices for navigating regulatory requirements and ensuring that all changes are well-documented and assessed for compliance impact.
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$199.00
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