Annex 1 – Aseptic Manufacturing|company
Understand the Requirements for Sterile Medicinal Products and Learn How to Apply Them in Your Organisation
Sterile medicinal products place extremely high demands on the environment, equipment, processes and behaviour.
This company-focused course gives employees an overview of Annex 1 and strengthens their ability to assess, document and prevent contamination in everyday practice.
Robust SOPs – Your Key to Compliance|company
Learn how to write SOPs that are easy to understand and support compliance.
Write SOPs that are read, understood and followed.
In this course, employees gain practical tools to make instructions clearer, more useful and easier to follow in practice.
The Effective Support Professionel|company
Strengthen Your Role in Collaboration with QA, Operations and Management
As a support professional, employees need to be able to act professionally and apply their professional expertise – even in challenging situations.
GMP Documentation – Get It Right|company
Good Documentation Practices: Clear, Correct and Traceable
Documentation is a key element of GMP and essential for patient safety.
It is rarely the major errors that cause problems. More often, it is the small details in the documentation.
Get to grips with good documentation practices and avoid errors in your everyday work.
GMP – from Regulatory Requirements to Everyday Practice|company
Understand Regulatory Requirements in Your Everyday Work
Do you understand why you do things the way you do?
And do you know how much of a difference your individual contribution makes to the finished medicinal product?
Qualification and Validation – from Requirements to Testing|company
Get the Basics of Qualification and Validation
Gain an understanding of the requirements for qualification and validation when new equipment or processes are introduced in pharmaceutical manufacturing – and learn how to ensure traceability from requirements to testing.
Learn from Your Own Cases and Create a Shared Direction|company
Take part in a facilitated workshop where you set aside dedicated time to understand and learn from your own cases.
Do you have deviations, SOPs, audit findings, collaboration challenges or other production-related cases that would benefit from dedicated time together to gain insight and capture important learning?
From Compliance to a Culture of Quality|company
When Quality Becomes More Than Compliance
Learn how to translate GMP into everyday practice so that you not only comply with requirements, but also actively contribute to a strong quality culture that supports patient safety, data integrity and collaboration.
Good Documentation Practice|company
Effective GMP Documentation in Your Organisation
Gain a clear understanding of regulatory requirements for proper GMP documentation and learn how to correctly complete and make corrections to batch documentation in a GMP-regulated environment.
Process Validation
Gain control over your process validation
Learn how to ensure product quality throughout its lifecycle. This course provides in-depth knowledge of process validation, including the application of advanced tools and an understanding of regulatory requirements from the EMA and FDA.