Quality Agreements in GxP
Are the company's quality agreements under control?
This course is for anyone who wants to learn everything about quality agreements or simply wants tips on how to improve them so you’re ready for an inspection. Learn what should and shouldn’t be included in the agreement.
Regulatory Life Cycle Management
Marketing authorizations are in the spotlight
What happens in the Registration Department after the initial marketing authorization is granted?
Understand the principles and requirements for maintaining a marketing authorization for a human medicinal product in Denmark and the EU.
GMP for IT Managers
Understanding Regulatory Requirements for IT in the Life Sciences
Here, we take a close look at the requirements for IT and the operation of computer systems. You’ll gain insight into and a practical understanding of both GMP requirements and their implementation, so you can ensure compliance in the development, operation, and maintenance of IT systems.
This course is essential for IT managers who want to master the complex rules and guidelines.
Train the Trainer
Effective on-the-job training for your colleague in production
This is a results-oriented 2-day course designed for operators or those in similar roles who need to provide on-the-job training to their colleagues in practical work tasks. You’ll learn to conduct training using a method tailored to the way the brain learns, ensuring that the training is both effective and a positive experience for everyone.
Update to Annex 11, Chapter 4, and new Annex 22
Understand the implications so you're ready when the changes take effect
Spend a day with an expert from one of the EU’s working groups on data integrity and gain insight into the rationale behind the proposed changes.
Variations in Tablet Production
Take Control of Your Tablet Challenges
Gain a thorough understanding of the technical aspects and find inspiration for solving problems in tablet manufacturing processes. You’ll be guided through the various stages of tablet manufacturing and the factors that can cause variations in tablet production.
Pharmaceutical Water Systems: Theory and Practice
Design, commissioning, operation, and maintenance of pharmaceutical water and pure steam systems
You will gain insight into regulatory requirements, guidelines, and relevant GMP principles, which will ensure optimal operation and quality of your pharmaceutical water and steam systems. This course combines theory and practice to provide you with in-depth insight into how to effectively manage, monitor, and maintain these essential systems.
QP – Qualified Person
Focus on Responsibility: Explore the Role of the QP
Become an expert in the QP role.
Get a handle on your responsibilities and current EU GMP requirements in two days.
Effective Quality Assurance as a QA Specialist
Optimize Your Impact and Increase Your Influence
This course focuses on how to understand and ensure compliance with GMP requirements, so you can become an even better QA professional. You’ll gain practical tools you can use in your daily work when handling cases, during discussions, and when communicating GMP requirements. We’ll focus on the personal qualities that come into play as a QA professional, so you’ll be able to fulfill your QA role to the best of your ability.
Ready for an IT audit
Know the requirements, and look forward to inspections by the authorities
This course will enable you to handle regulatory inspections of IT systems. After completing the course, you will be familiar with the requirements and strategies for IT validation. You will be able to present your validation to the authorities, helping them gain confidence in your approach to IT compliance.