Ready for Inspection|company
Be Ready for Your Next Regulatory Inspection
Understand the requirements, roles and appropriate conduct before, during and after an inspection. Employees receive practical advice to help your company approach the inspector calmly, knowledgeably and professionally.
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.
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.