Pharmaceutical GMP and Quality Systems
From Regulatory Requirements to Practical Implementation

Course Overview

This comprehensive course bridges the gap between academic theory and real-world industry
expectations, preparing you for a successful career in a highly regulated pharmaceutical
environment. Participants will gain a deep, practical understanding of core GMP principles,
quality management systems (PQS), documentation, validation, and critical compliance tools
like CAPA and change control.

By the conclusion of this training, you will possess the foundational expertise required to
design, implement, and maintain quality systems that guarantee product safety, efficacy, and
strict regulatory compliance across QA, QC, and manufacturing roles.

Learning Outcomes

• Identify the principles and regulatory requirements of Good Manufacturing Practices
  (GMP).
• List the structure and components of Pharmaceutical Quality Systems (PQS).
• State deviation management, CAPA, change control, and validation systems.
• Identify career pathways within pharmaceutical manufacturing and quality functions.
• Recognize the relationship between GMP compliance and product quality.
• Identify inspection readiness and regulatory audit requirements.
• Apply principles of good documentation practices and data integrity.

Prerequisites

• Basic knowledge of pharmaceutical sciences.
• No prior industrial experience required.

 

Who Can Attend

• Pharmacy graduates
• Senior pharmacy students
• Teaching assistants
• Fresh graduates
• Regulatory Affairs Beginners
• Professionals seeking careers in pharmaceutical manufacturing and quality systems

Course Contents

Module 1: Introduction to Pharmaceutical GMP & Quality Systems

Building a Culture of Pharmaceutical Quality

• GMP principles, history, and regulatory expectations
• Pharmaceutical Quality Systems (PQS) and Quality Risk Management (QRM)
• Quality culture and continuous improvement

Module 2: Documentation, Personnel & Data Integrity

Establishing GMP Foundations

• Personnel responsibilities, training, and GMP behavior
• Good Documentation Practices (GDP)
• Standard Operating Procedures (SOPs) and Batch Manufacturing Records
• Data Integrity (ALCOA+) principles

Module 3: Facilities, Equipment & Validation

Controlling the Manufacturing Environment

• GMP requirements for facilities, utilities, and equipment
• Equipment qualification, calibration, and maintenance
• Validation lifecycle, including process and cleaning validation

Module 4: Compliance, Audits & Continuous Improvement

Maintaining GMP Compliance

• Deviation management, Root Cause Analysis (RCA), CAPA, and Change Control
• Internal audits, regulatory inspections, and inspection readiness
• Continuous improvement and maintaining a state of GMP compliance

Module 5: Practical Workshops & Pharmaceutical Industry Experience

Hands-on GMP Application
Conducted through interactive workshops and guided visits to reputable pharmaceutical
manufacturing facilities.

Course Duration

Total Duration: 16 Contact Hours (3 Days)

• 10 Contact Hours: Interactive theoretical sessions (Modules 1–4).
• 6 Contact Hours: Hands-on practical workshops and industry-based learning
  (Module 5), conducted in collaboration with reputable pharmaceutical manufacturing
  facilities.

Certificate

Participants who successfully complete the course will receive a Certificate of Completion issued
from MIU.

Attendance Policy

Participants must attend at least 75% of the total contact hours to be eligible for the Certificate of
Completion.

Fees

• Non-MIU Participants: EGP 3,000
• Corporate Registration: EGP 2,500 per participant
• MIU Students and Graduates: EGP 1,500