Good Manufacturing Practices for Medicines and GMP inspections

Course programme
Online course (ENGMP010) - September 2019

Introduction

This e-learning course introduces Good Manufacturing Practices for medicines. The course focuses on the standards set forth by the WHO as one of the most important promoters and enforcers of GMP. Course participants will learn about the GMP requirements and their procedural, organisational and infrastructural repercussions. They will also learn about and get prepared for the GMP inspection process. 

At the end of the course, successful participants from local manufacturers and national regulatory authorities will be able to critically analyse and implement basic GMP requirements in their daily working routine in the manufacturing and regulatory environment. They will thus be better equipped for the production and regulation of quality assured essential medicines in line with national and international standards.

If you are interested in this course, do not hesitate to contact: training@iplussolutions.org

Course duration

14 weeks

Start date: Monday, 23 September 2019 13:00 (UTC)

End date: Thursday, 1 January 1970 13:00 (UTC)

Level of effort:

Course schedule


Week 1
23/09/19
Development of medicines regulations
Good manufacturing practices
Week 2
30/09/19
Quality management
Personnel, organisation and training
Week 3
7/10/19
Sanitation and hygiene
Premises
Equipment
Week 4
14/10/19
Materials
Good practices in production and quality control
Qualification and validation
Week 5
21/10/19
GMP requirements for documentation
Complaints and recalls
Self inspection and quality audits
Week 6
28/10/19
Introduction to GMP inspections
The role of the inspector
Types of GMP inspections
Inspections and inspection report
Course completion
Printer-friendly version
or