Change Management in Regulated Pharma Industries
About Course
Change management is a critical component of the Pharmaceutical Quality System (PQS), ensuring that changes to pharmaceutical materials, suppliers, formulations, manufacturing processes, equipment, facilities, analytical methods, and computerized systems are properly evaluated, approved, implemented, and monitored. Poorly managed changes can affect product quality, process validation, regulatory compliance, and patient safety.
This online course provides a practical understanding of pharmaceutical change management in accordance with applicable regulatory expectations, including ICH Q9, ICH Q10, FDA requirements, EU GMP, and PIC/S guidance.
What You Will Learn:
- Types and Categorization of Changes in Pharmaceutical Operations
- Sources and Triggers of Pharmaceutical Changes
- How to Write an Effective Change Control Proposal
- Impact Assessment of Pharmaceutical Changes
- Quality Risk Management in Change Control
- Change Control Review and Approval Process
- Implementation of Approved Changes
- Change Effectiveness Check and Closure
- Regulatory Expectations for Pharmaceutical Change Management
Who Should Enroll:
- QA Professionals
- Industrial Pharmacists
- Compliance Personnel
Course Format:
- Self-paced online modules
- Lifetime access
- Quizzes & certification upon completion
Course Content
Module I
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Introduction to Change Management in Pharma
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Types of Changes in Pharmaceutical Operations
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Categorization of Changes
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Sources and Triggers of Pharmaceutical Changes
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Assessment-1
Module II
Module III
Module IV
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