Introduction to this course: 

This course provides a comprehensive overview of the guidelines according to the current EU GMP Part I. This guideline consists of 9 chapters covering the basic requirements for the manufacture of medicinal products in the European Union, with the objective of ensuring product quality and safety through proper manufacturing and environmental controls.

Who should attend: 

This course is designed for professionals involved in the manufacturing and quality assurance of products, particularly in industries like pharmaceuticals, biotechnology, and medical devices. Individuals who should attend a GMP course include QA/QC, Technical Operations, Regulatory Affairs, R&D, Supply Chain, Validation, Maintenance, and Engineering.

Learning Outcomes: 

By the end of this lesson, you will be able to:

• Recall the nine chapters of EU GMP Part I and identify each chapter's focus area, such as Pharmaceutical Quality System and Personnel responsibilities.

• Describe the key principles and regulatory requirements of GMP in pharmaceutical and medical device manufacturing.

What will I gain: 

Participants will gain a comprehensive understanding of EU GMP Part I guidelines, equipping them with the knowledge to implement and maintain compliant pharmaceutical manufacturing practices. They will also develop practical skills in quality management, risk assessment, and documentation.

Prerequisites: 

Prerequisites for this course include basic knowledge of pharmaceutical and medical devices manufacturing, familiarity with Quality Management Systems, and basic knowledge of technical aspects like personnel training, equipment usage, testing procedures, and manufacturing processes in the life sciences context.

Additional information: 

Course duration: 00:47:02

Course code/version (effective date): L-103/v1.0 (26/05/2023)