- Cet évènement est passé.
SPEAKER: Aseptic Manufacturing – Maintaining the Validated State | Copenhagen, Denmark
juin 14, 2022 - juin 15, 2022
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.
Conference outline
Download the full agenda with speaker presentations (updated 21 July 2021) →
Day 1, November 15th
Moderator: Laurence O’Leary, ValidEire Aps
- Intro to Day 1 by Moderator
- EU Annex 1- Manufacture of Sterile Medicinal Products
Pierre Devaux, Theraxel - System Real Time Data Integrity, Electronic Sample Collection in Controlled Areas.
Susan Cleary, Novatek International - Plenary Q&A
- Validation of Lyophilisation for Parenterals
Kirstie Goggin, MTL projects - Equipment and Facility design of an Aseptic Facility
Robert J. Hayes, SeerPharma (UK) - Cleanroom and Contamination Control Strategy
Pierre Devaux, Theraxel - Plenary Q&A / Wrap up
- Snack and refreshments
Complimentary of Novatek International
Day 2, November 16th
Moderator: Pierre Devaux, Theraxel
- Intro to Day 2 by Moderator
- Media Fill studies
Gavin Ross, Founder, GTR Pharma - Aseptic training with VR
Sebastian Scheler, CEO & Lead Psychologist, Innerspace - Plenary Q&A
- Annex 1 & Environmental monitoring
Matt Kite, Lighthouse Worldwide Solutions - Temperature Mapping – Validation and Temperature Measurement
Enrique Riis, Ellab - Processing and transfer of primary packaging material for sterile production and transfer to the filling line
Jana-Cathrien Müller, Atec Steritec GmbH - Plenary Q&A / Wrap-up
Conference objectives
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 stateThe 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.
Who should attend
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