WORKSHOP 1: GMP-COMPLIANT DOCUMENTATION
Inspections mostly do not take place in the production area but in the office. Procedures, standard documents, and their compliance are checked based on documents. This also applies to the technical area. In this practical exercise, you will learn to identify errors in technical GMP documents and how to avoid them.

 

 

The GMP-compliant design of a production facility is the focus of the second workshop. Using examples, you will learn how to design facilities for a given process flow and critically evaluate costs.

 

WORKSHOP 3: IMPACT ASSESSMENT
For each process chain, it is necessary to identify systems with a quality impact and specify the corresponding validation steps. In this workshop, you will gain insight into typical equipment lists from pharmaceutical manufacturing areas and conduct a systematic evaluation of the equipment as a team. As a validation leader, you will discuss, assess, and decide on the quality impact. Your work results form a typical work package on the way to an appropriate qualification/validation strategy.

 

The risk analysis is the central element in plant planning and becomes a key guide in qualification. In the fourth workshop, user requirements (URS) are established, and based on this, the creation of a risk analysis is explained and practiced.