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Change Control and Regulatory Impact Assessment
- 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.
- Discussion of 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.
Overview of the webinar
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 webinar will focus 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 the complexities of regulatory requirements and ensuring that all changes are well-documented and assessed for their impact on compliance.
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?
In regulated industries, managing changes to processes, equipment, or materials is critical for maintaining compliance and ensuring product quality. Without a structured approach, uncontrolled changes can lead to regulatory violations, operational inefficiencies, and potential risks to patient or consumer safety.
This webinar will equip participants with the knowledge and tools to implement robust change control processes, conduct thorough regulatory impact assessments, and align their change management practices with FDA and ISO standards.
By attending, you will:
- Strengthen Compliance – Learn how to effectively document, evaluate, and implement changes while staying aligned with regulatory expectations.
- Improve Efficiency – Streamline your change control process to reduce delays, minimize risks, and enhance overall operational effectiveness.
- Enhance Risk Management – Understand how to assess the impact of changes to mitigate potential compliance gaps before they become issues.
- Stay Audit-Ready – Ensure your change control documentation meets FDA and ISO scrutiny, reducing the risk of findings during inspections.
- Apply Best Practices – Gain insights from industry experts on real-world strategies for navigating regulatory complexities.
Whether you're in Quality Assurance, Regulatory Affairs, Manufacturing, or Operations, this training is essential for anyone responsible for managing changes in a compliant and efficient manner.
Faculty - Miss.Meredith Crabtree
Meredith Crabtree has over 25 years’ experience in regulated industries ranging from Pharma, Medical Device, Biologics, Laboratory testing, Cosmetics, and Supplements. She has worked in both manufacturing and distribution as well as Human Health and Animal Health. Meredith currently works as a Quality Consultant performing label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality training. Meredith has a degree in Medical Technology and is currently obtaining a degree in Quality Systems.