GMP in Pharma Constructions
Design pharmaceutical facilities and areas with GMP in mind from the very first design step
Learn the essential regulatory knowledge you need to design or renovate areas within pharmaceutical facilities. Understand key design requirements early and reduce the risk of redesign, delays, and compliance issues.
Design and Implementation of Quality Management System (QMS)
Learn how to build a compliant and user-friendly QMS with practical tools
Gain insight into the regulatory requirements for Quality Management Systems for pharmaceuticals, medical devices, and combination products, and be introduced to practical examples of Quality Management Systems in organisations of different sizes and levels of complexity.
Navigating Drug–Device Combination Products (CP’s)
Cross-functional development and lifecycle management of CPs: assessing risks and interfaces
Learn how drug and device components come together throughout development, approval, and lifecycle management. Focus on risks, interfaces, and practical cross-functional challenges (i.e., EDDOs), with clear examples from EU and US regulatory expectations.
Mastering GMP Inspections
Gain practical tools to prepare for, host, and follow up on regulatory GMP inspections
This course provides practical guidance on how to prepare your organisation, manage the inspection process, and respond effectively after the inspection. A key strength of the course is the combination of practical industry experience and direct regulatory insight from an experienced GMP Inspector from the Danish Medicines Agency.
Annual GMP
Updating is the key to success in life science
Get documentation of maintained GMP knowledge, insight into current GMP trends, and the opportunity to exchange experience with colleagues from life science.
Root Cause Analysis and CAPA
Become an expert in handling problems and improve quality
Gain insight into the techniques behind Root Cause Analysis (RCA) and learn how to plan and implement effective Corrective and Preventive Actions (CAPA) to ensure continuous quality improvement.
Basic GMP
Understand GMP and learn how companies work with it in practice
This course, including evening activities and an overnight stay, provides you with a solid foundation in GMP. You will learn through case work, exercises, and a GMP game.
The course also gives you the opportunity to network with others who are new to life science.
Requirements for Production Facilities and Equipment in a Controlled Environment|company
Learn How Facilities and Equipment Support Product Quality
Employees gain insight into GMP requirements for facilities and equipment and an understanding of how facilities and equipment support quality, compliance and patient safety.
Introduction to the Manufacture of Sterile Medicinal Products for Operators|company
Get New Operators Ready to Work in Your Sterile Manufacturing Environment
The course prepares new operators to work in accordance with GMP requirements in your organisation and gives them a clear understanding of the requirements that apply to sterile manufacturing.
At the same time, they are introduced to the mindset required when working with the manufacture of sterile medicinal products in a GMP-regulated organisation.
Basic GMP for New Operators|company
Get New Operators Ready to Start in Your Pharmaceutical Manufacturing Environment
This course is a condensed two-day programme aimed at new operators in your organisation.
It provides a basic understanding of GMP requirements and the requirements that apply to working in pharmaceutical manufacturing. At the same time, employees gain a shared foundation for their further training within the organisation.