Change Control Management (CCM)

This Change Control Management (CCM) webinar, designed by an experienced industry expert, provides personnel with a comprehensive understanding of CCM requirements in regulated industries such as pharmaceuticals. It covers the essential principles, regulatory expectations, and best practices needed to ensure effective change management and compliance. What makes this course unique is its in-depth focus on key regulatory requirements, ensuring participants gain practical knowledge they can immediately apply in their workplaces.

WHY YOU SHOULD ATTEND: 

Change Control Management (CCM) is a critical process in regulated industries, ensuring that any changes to systems, processes, or products are assessed, documented, and implemented in a controlled manner. Proper CCM helps maintain compliance with regulatory requirements, minimizes risks, and ensures product quality and patient safety.

This webinar provides a structured approach to understanding and implementing effective change control. You will learn how to assess the impact of changes, manage documentation, navigate approval processes, and address common challenges in CCM. The session offers practical insights, and best practices to help you strengthen compliance, improve operational efficiency, and avoid costly regulatory violations.

By attending, you will gain the knowledge and skills needed to confidently manage change within your organization, ensuring a seamless and compliant transition while maintaining product integrity and business continuity.

LEARNING OBJECTIVES: 

• Understand fundamental concepts of Change Control Management (CCM).
• Learn roles and responsibilities in the Change Control process.
• Familiarize with change control procedures and documentation requirements.
• Classify and prioritize different types of changes.
• Assess the impact of changes on quality, validation, training, and regulatory compliance.
• Master best practices for tracking, approving, and implementing changes.
• Recognize common challenges and GMP deficiencies related to change control.
• Identify key regulatory requirements and industry best practices.

AREAS COVERED:

* You will also receive a Whitepaper 'Change Control Management: An Overview’ by Pavithra Bharathy and Shabna Roupal Morais 

• Introduction
• Regulations Overview  
• Key Definitions
• Scope of the Change Control 
• Responsibilities 
• Change Control System Procedure and Documentation Requirements
  • Assignment of tracking number
  • Change control sources 
  • Description of the change 
  • Justification of the change 
  • Change control committee
  • Assess quality, validation, training, and regulatory impact 
  • Change control classification 
  • Schedule of event / action and timeline
  • Approval process
  • Action plan communication
  • Follow-up and implementation 
  • Pending status for changes
  • Final documentation and record retention 
  • Trending
• General Considerations
• What Makes Change Control so Challenging?
• Recommended Best Practices in the Change Control Process
• Successful Change Control System   
• Benefits of Change Management System
• GMP Deficiencies Related to Change Control
• Change Control SOP
• Q&A

 WHO SHOULD ATTEND: 

• Quality Assurance Departments
• Quality Control Departments
• Manufacturing Departments
• Production Departments
• Research and Development Departments
• Compliance Departments
• Engineering Departments
• Validation Personnel 
• Auditors and Inspectors 
• Regulatory Affairs Departments
• Everyone who need a fundamental understanding of the Change Control Management requirements for pharmaceutical products

Course Director: Esraa Abu-Karaki

Esraa Abu-Karaki is a seasoned expert with over 20 years of experience in quality management, compliance, and continuous improvement within the pharmaceutical industry. She has held leadership roles at leading pharmaceutical companies, including Hikma Pharmaceuticals. Esraa specializes in auditing, training, quality system development, and digital transformation. She has established and led multiple departments, including the Corporate Quality Department, driving quality excellence. She has successfully prepared pharmaceutical facilities for inspections, leading and playing a crucial role in securing certification and recertification of multiple sites by global regulatory authorities, such as the EU and US FDA. Her work ensures compliance with GMP and GxP standards, strengthens regulatory compliance, and improves and unifies quality systems through the development and implementation of comprehensive quality policies. As an independent consultant and trainer, Esraa provides expert guidance on pharmaceutical quality systems, data integrity, and regulatory compliance. She has trained professionals across various regions, making complex regulations practical and easy to implement through structured training and hands-on experience.