Pharmaceutical industry employees involved in a new construction or alteration project are invited to attend this event. Expert knowledge, tips and suggestions will be shared for realising projects on time and reducing costs by consistently taking the GMP requirements, rules and guidelines into account in project management right from the early planning phase. Reliably and with no waste of resources.
The agenda includes thematic blocks on the project concept and implementation, GMP schedule, the building permit and interacting with public authorities, efficient project organisation, protection concepts, FDA inspections, new construction and alterations, and clean room projects from the perspective of the drug authorities.
Experts from gempex Switzerland are taking part with two technical presentations:
GMP Schedule:
- When do the first GMP ideas come up?
- How do you keep track of them?
The presentation clearly describes in which of the typical project phases URS for example or the first risk analyses can be integrated, and uses case studies to demonstrate the measured, ideal integration of the GMP requirements. Because “too much” can be damaging in view of resources.
FDA inspections for new construction and alterations:
- Current requirements.
- The art and science of FDA clean room inspections.
This presentation offers valuable basic knowledge for dealing with FDA inspections professionally, including preparation and follow-up. Numerous tips about dos and don’ts are shared based on practical examples and the review of warning letters and defect reports.
For further information and to register, please visit
SwissCleanroomConcept.
You are also welcome to contact the gempex expert team in Sisseln on this topic: