GMP (Good Manufacturing Practice) refers to the quality systems commonly applied in pharmaceutical production. However, other sectors within Life Sciences, such as the development and manufacturing of medical devices, must also adhere to similar quality standards.

This introductory course provides an overview of the rules and guidelines that govern how quality systems can be applied across these areas. While the course primarily focuses on pharmaceutical regulations, it also briefly addresses regulatory requirements and ISO 13485 standards for medical devices.

Course Content: 

- Introduction
- History About GMP
- Basic Rules of GMP
- Validation
- Authority inspections
- Good Documentation Practice

Prerequisite for participating at this course is certified participation at the Life Science Intro course.