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GMP Awareness for Management
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GMP Awareness for Management

Updated Tuesday, 14 April 2026 at 17:25

Essential GMP fundamentals and management responsibilities in pharmaceutical manufacturing

One trainer, one team, your site

Run for your team at your location. We adapt the material to your products, SOPs and recent inspection findings — taught by the same trainers who run our public PCS Academy courses.

Request a custom training quotation

What's included

  • Programme adapted to your products and SOPs
  • Trainer travels to your site — no staff time lost
  • Dates that fit your production schedule
  • Individual certificate for every participant
  • Same trainers who teach our public PCS Academy courses

Difficulty

Beginner level

Topics

GMP EudraLex Volume IV Medicines Act Management Review Data Integrity Impact Assessment Risk Assessment Quality Awareness Trending Documentation IGJ

Categories

Good Manufacturing Practice (GMP) | GMP Training

Also available as in-house

What you will learn

Understand the definition of GMP (cGMP) and its historical context

Explain why GMP exists and its importance for patient safety and product quality

Identify key European regulations (Eudralex Volume 4, EU Directives, EMA guidelines)

Recognize the relationship between GMP and business processes

Describe management's responsibilities in implementing and maintaining GMP

Understand the basics of equipment qualification and process validation

Appreciate the quality management system approach to GMP compliance

Description

This half-day training provides management personnel with a comprehensive understanding of Good Manufacturing Practices (GMP), its regulatory foundation, and management's critical role in ensuring pharmaceutical product safety and quality.

Participants will learn why GMP exists, how it relates to business processes, and how to establish and maintain a quality management system that meets regulatory requirements. The training emphasizes the integration of GMP into daily operations and the importance of leadership commitment to quality.

Target Audience

Managers, team leaders, and supervisory personnel in pharmaceutical manufacturing, quality assurance, and operations who need foundational knowledge of GMP and their role in quality systems.

Contents

Introduction to GMP fundamentals, regulatory landscape (EU directives and EMA), the pharmaceutical chain and quality management, management responsibilities, and key concepts of equipment qualification and process validation.

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Programme

Results

Participants will be able to explain GMP principles, understand regulatory requirements, recognize management's role in quality systems, and appreciate the importance of qualification and validation in pharmaceutical operations.

Request a custom training quotation

Tell us a bit about your team — head count, the topics you need covered, your preferred dates and your site location. We will come back with a tailored proposal and price, usually within one working day.