The seminar “Efficient Project Management” imparts specific expert knowledge and offers tips, assistance and suggestions for everyone involved in clean room alteration and new construction projects. Topics on the agenda include the project idea and implementation, the building permit and interacting with public authorities, efficient project organisation, protection concepts, FDA inspections and the perspective of the drug authorities.
Participants learn how to conserve resources through substantiated expert knowledge and the early integration of the GMP requirements from planning to realisation. gempex Switzerland is an expert in this field and was invited to give two presentations based on its extensive practical experience.
The presentation “GMP Schedule” identifies the project phases in which it is meaningful to take initial GMP considerations into account, and helps integrate them to the correct extent and consistently track their implementation.
Current requirements and the art and science of FDA clean room inspections are core topics of the presentation “FDA Inspections for New Construction and Reconstruction”. This presentation offers valuable basic knowledge for dealing with FDA inspections professionally, including preparation and follow-up. Practical examples, insights into warning letters and defect reports as well as dos and don’ts complete the presentation.
For further information and registration, visit the website of the organiser SCC Swiss Cleanroom Concept.
The expert team of gempex Switzerland will be happy to answer your questions on the topic: