This two-day intensive summit brings together the industry leaders in compliance, aseptic manufacturing and maintaining the validated state. The conference will go beyond presentations on best practice and 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 new Annex 1 draft, FDA focuses on inspecting sterile facilities, sterilisation, process validation, life cycle approach and more. The conference will showcase some of the tech that impacts aseptic manufacturing.
In addition to the many presentations and workshops, the conference will also provide many opportunities for networking. Read more about the individual presentations in the full agenda.
The conference will be a hybrid event, and this enables attendees to either view online or be physically present at the event. We believe this is optimal for our customers in the current climate and hope you will attend.
Day 1, October 21st
Moderator: Laurence O’Leary, ValidEire Aps
Day 2, October 22nd
Moderator: Pierre Devaux, Theraxel
The objective of this conference is to provide participants with practical knowledge and understanding of regulatory requirements and techniques that can be put to use in their own aseptic manufacturing process strategy. The presenters will focus on the newest information available and will cover a wide range of subjects relevant to aseptic manufacturing and maintaining the validated state.
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.
This course is intended for:
We have created a conference model that accommodates the best experience for all attendees in the current global Covid-19 situation. We hope to facilitate for more attendees and the conference price also is reduced significantly to open up for a wider audience.
All presentations will be pre-recorded in September 2020 as speakers’ local time zones will not be optimal for presenting with local times in central European time (CET) when the event is hosted. These will however be broadcast at the times displayed in the table and available prior and after the conference to view at no further cost.
The speakers will be present in real time and available to answer questions either relayed beforehand by mail or live at the plenary Q&A. These will be broadcast at the times displayed in the table and be available after the conference to view at no further cost.
The workshops also will be in real-time and dual communication between the facilitator and attendees will be possible either through a chat function or via microphone managed by the moderator. These will be broadcast at the times displayed in the table and be available after the conference at no further cost.
This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.
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