GMP MasterClass

Note. The Swedish version of this course is offered November 18-19, 2025 →

This course gives you a comprehensive review of GMP compliance requirements and tools to master application and interpretation of these requirements. This course is aimed to take you further in your understanding of GMP requirements and will assist you in your daily challenges either working in QA or with GMP related tasks in other parts of a pharmaceutical operation.

Course description

The course is a 2-day highly interactive course led by our experienced trainers where participants explore the different elements of GMP through theory, group exercises, discussions and knowledge exchange. As a preparation for the live training, you will get a home assignment to complete in your own pace before the face-to-face training.

During the 2-day training you will learn to understand, navigate, interpret and apply GMP according to requirements in both EU and US GMP as well as in line with up-to date views on ICH guidelines on Pharmaceutical Quality System and Quality Risk Management.

The course material will include references to specific requirements, guidelines and interpretations from authorities and regulatory associations.

Course outline

Home assignment in preparation for training:
Case study – What GMP Requirements are relevant in the EU and the US?

2-day training:

• The foundation for GMP-requirements
• Quality risk management and application in GMP-environment
• Process and production controls
• Material and supplier controls
• Personnel
• Document control and data integrity
• To stay in control throughout the product life cycle
  • Trending, PQRs, Self-inspection and Change management
• If control is lost
  • Deviations, complaints, CAPA
• Quality Management System and Quality Culture

Case -study exercises, challenges and discussions for the different areas

Learning objectives

After this course, you will have a full overview of the contents of both EU and US GMP. You will also be able to distinguish between requirements, interpretations and industry practice. You will be equipped with tools and strategies to navigate the universe of GMP guidance documents and have enhanced your ability to apply current GMP requirements to potential challenges in the daily operations of a GMP environment.

Who should attend

The course is suitable for persons working with development, production, QA or QC, who is involved in operation or audit of pharmaceutical quality systems.

Prerequisites

• You should have basic knowledge of GMPs, e.g. by participating in one of our basic courses or have equivalent knowledge.
• You should have at least 6-12 months experience of working in the regulated industry (Pharmaceutical manufacturing).

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