Introduction to this course: 

This course covers essential principles of change management, exploring processes, responsibilities, and key concepts, and provides practical advice on creating an effective change management plan, as well as tracking and monitoring change implementation.

Who should attend: 

This course is designed for professionals who are involved in managing and implementing changes and seeking to enhance their skills: QA/QC, regulatory affairs, manufacturing and production, compliance, and auditors.

Learning Outcomes: 

By the end of this lesson, you will be able to:

• Analyze the importance of change management, identify key concepts such as change control and its regulatory requirements, and evaluate the necessity of implementing changes to maintain quality and compliance throughout the product life cycle.

• Evaluate the significance of effective change management practices, recognizing key responsibilities and procedures involved in implementing, assessing, and classifying changes.

• Differentiate between deviations and changes, thereby enhancing your ability to effectively manage deviations and implement appropriate change control measures to ensure compliance and maintain product quality.

What will I gain: 

Participants will gain insights into change control, impact assessment, and post-change evaluation. 

Prerequisites: 

Prerequisites for this course include a basic understanding of quality management systems and processes and familiarity with pharmaceutical industry regulations and standards (such as ISO 9001 and FDA guidelines).

Additional information: 

Course duration: 00:33:42

Course code/version (effective date): L-51/v1.0 (26/04/2023)