Driven by biopharmaceuticals but also prominent in small molecules drug manufacturing as well as for APIs, aseptic processing will undergo a technology jump start driven by the new EC GMP Guide Annex 1.

Globally supplying companies, which deliver sterile drugs to Europe, must comply with this new regulatory requirement. There is an impact for all stakeholders of manufacturing, across hierarchy levels and various functions at manufacturers. Also, suppliers have to consider Annex 1 when supplying new equipment or installing new production facilities.

This course will focus on aseptic processing and quality management regarding pharmaceutical technology. The training course will provide ample time in clean rooms for various practical exercises, allowing participants to engage in hands-on operations. These sessions will occur in the clean rooms of the EASE platform.

To meet the challenges of the new Annex 1 guide and enhance industry efforts to develop, manufacture and reliably deliver quality medicines to patients, ISPE is conducting a 3-day training event in a unique place, the European Aseptic and Sterile Environment (EASE) Facility in Strasbourg, France.

This training provides hands-on opportunities to interact with equipment in a facility school built for training pharmaceutical industry workers. For this hands-on session, attendees will have the opportunity to conduct aseptic exercises as well as ATMP manufacturing exercises in the clean rooms at the EASE facility including preparation and aseptic manipulation inside biological safety cabinets!