About This Program
This refresher course focuses on critical updates, high-risk areas, common inspection findings, and advanced application of GMP principles in day-to-day operations. Rather than re-teaching basic concepts, this program reinforces essential knowledge while introducing new regulatory expectations and industry best practices.
The course emphasizes:
Content is based on the latest revisions of EudraLex Volume 4, with special emphasis on Annex 1 (Sterile Products), Annex 11 (Computerised Systems) , and Annex 15 (Qualification and Validation).
This course is intended for all personnel who have already completed foundational EU GMP training and are actively working in GMP-regulated environments. The content is particularly relevant for:
| Audience Group | Relevance |
| Production and Manufacturing Staff | Execute processes and need to understand how their actions impact product quality and regulatory compliance |
| Quality Assurance and Quality Control Personnel | Review documentation, perform testing, and make quality decisions that require up-to-date regulatory knowledge |
| Warehouse and Logistics Staff | Handle materials and products, maintaining the supply chain and preventing mix-ups |
| Maintenance and Engineering Teams | Responsible for equipment, utilities, and facility systems that must operate within validated parameters |
| Supervisors and Department Heads | Lead teams and must ensure their areas maintain GMP compliance and address inspection findings |
Before starting this refresher course, you should have:
To successfully complete this training program and receive certification, you must:
| Requirement | Details |
| Module Assessments | Achieve a minimum score of 80% on all module assessments |
| Final Examination | Complete the comprehensive final examination with a score of 80% or higher |
| Completion | Complete all modules and assessments |
Upon successful completion of all module assessments and the final examination, you will receive a Certificate of Completion for the EU GMP Refresher Course.
Certificate Details:
We provide training programs designed to help you meet quality and compliance standards. Our courses cover GMP, GLP, GCP, GEP, GDP, and Quality Assurance.
