Quality Management System

Quality Management System (QMS)

✅ Build Compliance. Ensure Product Quality. Protect Patient Safety.

📘 Course Description

This comprehensive training is designed to provide pharmaceutical professionals with an in-depth understanding of Quality Management Systems (QMS) aligned with global regulatory expectations (FDA, EU GMP, ICH Q10). The course focuses on principles, elements, and implementation strategies essential for maintaining a compliant and efficient QMS in a GMP-regulated environment.

Participants will explore real-world scenarios, case studies, and tools to assess, implement, and improve QMS performance within their organization.

🎯 Learning Objectives

·         Understand the structure and purpose of a pharmaceutical QMS.

·         Prepare for audits and regulatory inspections with a robust QMS framework.

·         Establish quality metrics and continuous improvement practices.

·         Interpret key QMS elements from ICH Q10, 21 CFR Parts 210/211, and EU GMP.

·         Implement core QMS processes including CAPA, change control, deviation, risk management, and document control.

📚 Course Syllabus

Module 1

Introduction to Pharmaceutical QMS

Module 2

Core QMS Elements

·         QMS Principles and Lifecycle

·         Regulatory Expectations:

·         ICH Q10, ISO 9001

·         FDA/EU GMP.

·         Documentation & Record Control

·         Change Management

·         CAPA (Corrective and Preventive Action)

·         Deviation Management

·         Risk Management (ICH Q9)

·         Internal and External Audits

Module 3

Quality Metrics & Continuous Improvement

Module 4

QMS Integration and Inspection Readiness

·         KPIs and QMS Performance Monitoring

·         Quality Reviews and Management Responsibility

·         Root Cause Analysis (RCA) Tools

·         Knowledge Management and Training

·         Integrating QMS with CSV, Validation & Manufacturing

·         Audit Preparation and Mock Inspections

·         Case Studies and Best Practices

·         QMS Pitfalls & How to Avoid Them

📢 Enroll Today – Empower Your Team to Drive Quality Excellence!