Good Manufacturing Practice (GMP) training for pharmaceutical professionals
Get the practical knowledge, regulatory insight, and confidence to implement GMP standards that actually work on the ground. This expert-led training helps you master EU GMP guidelines (EudraLex Volume 4), avoid compliance pitfalls, and build a quality-driven culture from production to release.
Why this training matters
Compliance with GMP guidelines ensures that pharmaceutical products are consistently produced and controlled according to quality standards.
This training provides a comprehensive understanding of GMP principles, enabling participants to:
Understand what are your responsibilities in the Product Quality Reviews
Implement effective quality management systems.
Deep dive in the Annex 16 of the GMP
Ensure product integrity throughout the manufacturing process.
Maintain compliance with international GMP standards.
Who can attend
This program is ideal for individuals involved in the distribution of pharmaceutical products, including:
Quality assurance and quality control personnel
Qualified Persons
Release employees
Production managers and supervisors
Regulatory affairs professionals
Compliance specialists
Engineers and technical staff
Anyone seeking to enhance their understanding of GMP principles
Learning outcomes
Upon completion of this training, participants will be able to: |
Explain the purpose and core principles of GMP within the EU regulatory framework.
Interpret EudraLex Volume 4 requirements and translate them into real-world practices.
Identify and evaluate risks in manufacturing processes using quality risk management tools.
Apply GMP standards confidently in day-to-day operations across production and quality roles.
Analyze deviations, data, and process inconsistencies — and propose appropriate CAPAs.
Assess data integrity risks and apply ALCOA+ principles to ensure reliable, compliant documentation and record-keeping practices.
Design or improve documentation systems that ensure traceability, clarity, and audit-readiness.
Demonstrate a compliant, proactive mindset during audits, inspections, or internal reviews.
Syllabus
Our GMP training program covers essential topics to ensure comprehensive understanding and practical application: |
1.
Introduction to GMP
Understanding the principles and objectives of Good Manufacturing Practices.
Overview of the regulatory framework and guidelines.
2.
Quality management systems
Establishing and maintaining a robust pharmaceutical quality system (PQS).
Implementing quality risk management strategies.
3.
Personnel and responsibilities
Roles and responsibilities of key personnel, including the Qualified Person (QP).
Importance of training and competency in GMP compliance.
4.
Premises and Equipment
Requirements for manufacturing facilities and equipment.
Ensuring proper environmental controls and maintenance.
5.
Documentation and record-keeping
Principles of good documentation practices (GDocP).
Maintaining accurate records to ensure traceability.
6.
Production and process controls Traceability
Procedures for manufacturing operations to ensure consistency and quality.
Implementing process validation and control strategies.
7.
Quality control and laboratory operations
Conducting testing and analysis to verify product quality.
Managing laboratory controls and ensuring data integrity.
8.
Handling deviations and CAPA
Procedures for managing deviations and implementing corrective and preventive actions (CAPA).
Strategies for continuous improvement and compliance maintenance.
9.
Self-Inspection and Continuous Improvement
Conducting internal audits to assess compliance.
Meet Nelly, your trainer
Nelly’s approach to real-world quality
At MentorinQ, quality isn’t just a checklist — it’s a living process that drives better understanding, smarter workflows, and faster decision-making.
Our method focuses on three essential actions to make quality practical, human, and sustainable:
Train
Understand the real needs of your team. Create customized training that fits your challenges and turns regulations into practical tools — not obstacles. When people understand why they act, quality becomes a natural part of how they work.
Process
Start from your operational reality — not theoretical models. Together, we build clear, intuitive processes that are tested, flexible, and easy for your teams to apply consistently.
Monitor
Set up simple, effective tracking systems to access the right information at the right time. Make faster decisions, boost your team’s energy, and strengthen compliance — without drowning in bureaucracy.
