Pharmaceutical Change Control Management Training

 Pharmaceutical Change Control Management Training

✅ Control Changes. Maintain Compliance. Ensure Product Integrity.

📘 Course Description

This training equips pharmaceutical professionals with knowledge and tools to manage changes in a GMP-regulated environment systematically and compliantly. Participants will learn how to evaluate, document, implement, and verify changes across systems, processes, equipment, and documents without compromising product quality or regulatory compliance.

Aligned with FDA (21 CFR Part 211), EU GMP Annex 15, ICH Q10, and WHO GMP, this course emphasizes risk-based change assessment, impact evaluation, and cross-functional change coordination.

🎯 Learning Objectives

·         Understand regulatory requirements and expectations for change control.

·         Navigate the change control lifecycle: initiation, review, approval, implementation, and closure.

·         Identify changes that require formal control under GMP.

·         Link change control to other QMS elements (CAPA, deviation, validation, training).

·         Perform risk-based impact assessments (quality, regulatory, validation, safety).

·         Prepare documentation and evidence for audits and regulatory inspections.

📚 Course Syllabus

Module 1:

Fundamentals of Change Control

Module 3:

Implementation and Closure

·         Definition and Scope of Change Control

·         Types of Changes: Planned, Unplanned, Temporary, Emergency

·         Regulatory Requirements: FDA, EU GMP Annex 15, ICH Q10

·         Implementation Strategy and Verification

·         Documentation Updates, Training, and Validation Needs

·         Change Effectiveness Review and Closure Criteria

Module 2

Change Control Lifecycle

Module 4

Integration and Inspection Readiness

·         Change Request Initiation and Documentation

·         Impact Assessment: Quality, Validation, Regulatory, Safety

·         Cross-Functional Review and Approval Workflow

·         Change Control Integration with QMS Modules (CAPA, Deviations, Audits)

·         Common Inspection Findings and How to Avoid Them

·         Case Studies and Real-World Examples

📢 Register Today – Control Change Before It Controls Your Compliance!