Target Audience

All employees involved in pharmaceutical production and technology, quality control, and quality assurance are addressed, for whom the EU GMP guidelines require knowledge of GMP fundamentals. The course makes it easier for both new and experienced employees to understand the implemented or upcoming GMP measures and their practical application in the operation.

Objectives

In this GMP advanced training, you will gain an overview and expand your GMP knowledge, particularly in the areas of:

– Importance of the Quality Management System for GMP
– Risk Management
– Trending & Key Performance Indicators (KPIs)
– GMP-compliant documentation in practice
– Practical handling of deviations, CAPA, Change Control
– Auditing from the perspective of the auditee. What matters?

The implementation of GMP rules is a crucial aspect of the manufacturing and testing of medicinal products to produce and ensure high-quality products.

Ensuring continuous compliance and adherence to these rules by employees is therefore of vital importance. To do so, employees must know and understand the rules.

In addition to basic training, the EU GMP guidelines require ongoing education in GMP rules. Therefore, this event will illustrate, refresh, and expand the implementation of these rules through practical examples and workshops.