This two-day intensive summit brings together the industry leaders in compliance, aseptic manufacturing and maintaining the validated state. The summit will go beyond presentations on best practice, and it consists of both presentations and workshops on different aspects of aseptic manufacturing. Attendees will therefore gain a deeper understanding of the new messages from the revised Annex 1, EMA focuses on inspecting sterile facilities, sterilisation, process validation, life cycle approach, and more. The summit will showcase some of the tech that impacts aseptic manufacturing.
In addition to the many presentations and workshops, the summit will also provide many opportunities for networking. Read more about the individual presentations in the full agenda.
The summit will be a physical event, but some speakers may participate virtually in case of unprecedented events.
As an extra value adding part of the summit workshops and exhibitors will be available in a separate room for both days exclusive to this summit.
Here you will be able to meet other participants, speakers and exhibitors all specifically focused on Aseptic Manufacturing disciplines.
Day 1, TBD, Key2Compliance (Moderator)
Day 2, TBD, ValidEire ApS (Moderator)
The objective of this summit is to provide participants with practical knowledge and understanding of regulatory requirements and techniques that can be used in their own aseptic manufacturing process strategy. The presenters will focus on the newest information available, and they will cover a wide range of subjects relevant to aseptic manufacturing and maintaining the validated state.
The summit is primarily relevant for R&D staff, Production Leaders, Supporters, Commissioning, Qualification & Validation teams and Quality Assurance. Anyone looking to exchange experiences and seeking the latest knowledge about risk- and cross contamination control, as well as engineering companies wanting to learn more about the viewpoints of the pharmaceutical industry.
The conference is primarily relevant for R&D staff, Production Leaders, Supporters, Commissioning, Qualification and Validation teams and Quality Assurance seeking the latest knowledge about risk- and cross contamination control, as well as engineering companies wanting to learn more about the viewpoint of the pharmaceutical industry and exchanging experiences.
08:45-09:20 Registration, breakfast and networking
16:30-18:00 Workshops an Exhibition
18:00 . 19:30 Mingel
08:45-09:20 Breakfast and networking
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