To enhance industry efforts to develop, manufacture and reliably deliver quality medicines to patients, ISPE is conducting training events in a unique place, the European Aseptic and Sterile Environment (EASE) Facility in Strasbourg, France. These training events provide immersive and hands-on opportunities to interact with equipment in a facility school built for training pharmaceutical industry workers. Attendees will have the opportunity to conduct exercises in the classrooms as well as the clean rooms at the EASE facility including preparation and aseptic manipulation inside biological safety cabinets!
These training events are organized in 3-day and 4-day formats which cover 2 full ISPE courses in each event. Make the most out of your professional development investment by attending these immersive sessions at the EASE facility. Explore the combinations available below for more information on each event and content.
This event will cover the principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications. In addition, the HVAC content focusses control system alarm management, common system construction deficiencies, GMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.
The course will cover qualification and process validation, from EU and US perspectives, considering both small and large molecule aspects, plus it will include a half day to consider qualification and process validation for ATMPs.
This event will focus on aseptic processing & Annex 1 where attendees will work closely with fill and finish aseptic lines while instructors explain the various options for setting up the equipment as well as loading stoppers. Additionally, the course material establish guiding principles from the ATMP Manufacturing GPG that should be considered in the implementation of ATMP manufacturing processes.
Get connected with ISPE Professional Development and begin creating a training experience for your company today.
EASE - the platform for pharmaceutical engineering is located in the Ilkirch innovation park, a technological excellence site in the Eurometropolis of Strasbourg. In the heart of a tri-national geographical area (France, Germany and Switzerland) that brings together leading players in the pharmaceutical industry and biomedicine production (Sanofi, Lilly, Novartis). EASE the training facility is the only immersive industrial platform, that offers its customers a production environment similar to GMP standards - Good Manufacturing Practice - and designed to teach good manufacturing practices (GMP) in clean rooms and aseptics environments.
EASE, plant 4.0, allows process data from the machines to be monitored and collected, as well as measurements relating to the production environment (temperature, humidity, particulate pollution). EASE innovates and anticipates what the plant of tomorrow will look like.
The operating conditions of EASE emphasize a production tool that is always at the forefront of technology and regulatory requirements. The 2000 m² of clean rooms (ISO 5 to 8, similar GMP classes A to D) accommodate three process lines: the manufacture of dry forms (tablets and capsules), sterile liquid forms, injectables and biomolecules. These processes cover the stages from the reception of raw materials to primary