Good x Practice in the Pharmaceutical Industry (GxP)

Categories: Good x Practice
Share course
Page link
Share on social media

About course

If you are coming into contact with the pharmaceutical industry for the first time, the basic “Good Manufacturing Practice” training will give you the necessary insights into the how and why of the quality management system behind the development, production and distribution of medicines.

The cleanroom behavior training consists of a theoretical training that delves deeper into the sources of contamination in cleanrooms, how to work in a clean room, classifications of cleanrooms, and the influence of human behavior, changing procedures, cleaning, and disinfection. The importance of environmental monitoring is also discussed.

Target Group: Employees from the Pharmaceutical or Life Science sector:
Employees required to perform GMP tasks (operators, QC and QA staff, validation engineers, etc.) and related departments. Also engineers who work in a cleanroom environment (grade D, C and B)

Show More

What will you learn?

  • GMP (Good Manufacturing Practice)
  • GMP history
  • GMP legislation and regulations
  • GxP during Drug Life Cycle
  • Quality Systems
  • Overview of the most important Quality Systems
  • Good Documentation Practice (GDP)
  • Sources of Contamination
  • How a clean room works and classifications
  • Changing Procedures
  • Cleaning & Disinfecting (cleaning techniques)
  • Environmental controls in a cleanroom

Course content

Good Manufacturing Practice (GMP)
During this training session you will learn about following topics. The meaning of GMP, its origin and existing legislation. How different quality systems are built into a GMP production process and what they serve.

  • Good Manufacturing Practice
    25:54

Cleanroom Behavior
The cleanroom behavior training consists of a theoretical training that delves deeper into the sources of contamination in cleanrooms. How to work in a cleanroom and classifications of cleanrooms. The influence of human behavior, changing procedures, cleaning and disinfection. The importance of environmental monitoring is also discussed.

Student ratings & reviews

No Review Yet
No Review Yet

A course by

Alain Deloof
Alain Deloof
Senior GxP Consultant

In my current job at Advipro I'm project manager/senior consultant for several projects in cleanroom building/validation (Belgium and the Netherlands) and Manager for the GxP Academy.

At Normec Advipro, we ensure that your organisation in life science operations meets regulatory requirements and remains sustainably compliant. With our expertise in GMP, ISO standards, FDA, EMA, and other regulatory bodies, we implement smart solutions that comply with regulations and enhance operational efficiency. From project initiation to periodic requalification, we support you at every stage to optimise performance and manage risks.