GMP in Pharmaceutical Construction
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 on and reduce the risk of redesigns, delays, and compliance issues.
Design and Implementation of a Quality Management System (QMS)
Learn how to build a compliant and user-friendly QMS using practical tools
Gain insight into the regulatory requirements for quality management systems for pharmaceuticals, medical devices, and combination products, and learn about practical examples of quality management systems in organizations of various sizes and levels of complexity.
Navigating Drug–Device Combination Products (CPs)
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 based on EU and U.S. regulatory requirements.
Mastering GMP Inspections
Gain practical tools to prepare for, conduct, and follow up on regulatory GMP inspections
This course provides practical guidance on how to prepare your organization, 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 at the Danish Medicines Agency.
Annual GMP
Staying up to date is the key to success in the life sciences
Gain documentation of your ongoing GMP knowledge, insight into current GMP trends, and the opportunity to share experiences with colleagues in the life sciences.
Root Cause Analysis and CAPA
Become an expert in problem-solving 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 apply it in practice
This course, which includes evening activities and an overnight stay, provides you with a solid foundation in GMP. You will learn through case studies, exercises, and a GMP game.
The course also gives you the opportunity to network with others who are new to the life sciences.
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 within your organization and provides them with a clear understanding of the requirements that apply to sterile manufacturing.
At the same time, they are introduced to the mindset required when working in the manufacture of sterile medicinal products in a GMP-regulated organization.
Basic GMP for New Operators|company
Get New Operators Ready to Begin Work in Your Pharmaceutical Manufacturing Environment
This course is a condensed two-day program designed for new operators in your organization.
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 common foundation for their further training within the organization.