GMP Roadmap for Conversion and New Construction Projects

Technical lecture by gempex
-    Efficient project management for cleanroom conversion and new construction
-    SCC Seminar on 24.11.2022 in Rheinfelden, Switzerland

New construction and conversions are very expensive and time-consuming. In most cases, GMP requirements are not given much attention in the initial planning phases or are even neglected altogether. Nevertheless, regulations and requirements remain in place, so the initial cost savings may well lead to further conversions and time delays later on.

The GMP idea should be woven in from planning to realization. Value-added planned and well thought-out projects not only increase quality, but can even contribute to cost reduction.

Members of the pharmaceutical industry who are involved in the project of a new construction or a conversion are invited to attend this event.

GMP-roadmap for conversion and new construction projects  
On the occasion of this event, Ralf Gengenbach, Managing Director gempex GmbH, will present how a GMP-oriented project roadmap should look like in order to avoid surprises later on, for example when obtaining the manufacturing authorization. It is important to initiate and advance GMP activities at an early stage. When, what, with whom, all these questions are clarified. In addition, his presentation shows how best to integrate the suppliers involved in the project steps economically and in compliance with the regulations. 

The overall program highlights the complete project process from the project idea to the implementation of all requirements! Which critical success factors must be taken into account? How should a requirements specification be structured? What does an efficient project organization look like? What do I need to know when dealing with the authorities to be involved?

The focus is on various sectors of the life sciences, including food, pharmaceuticals and medical devices. At the end, each participant additionaly gets a good insight into the typical requirements of an inspection. 

Further information and the possibility of registration are provided by the organizer Swiss Cleanroom Concept. 

The gempex team of experts in Sisseln will be happy to answer your questions on this topic via