Aseptic Manufacturing

Aseptic Manufacturing- Maintaining the validated state

2023 new date and agenda coming soon!

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.

08:45-09:20Registration and breakfast
09:20-09:30Intro to Day1 by Moderator
09:30-10:15EU Annex 1 – Manufacture of
Sterile Medicinal Products
Pierre Devaux, Theraxel
10:15-11:00System Real Time Data
Integrity, Electronic Sample Collection in
Controlled Areas.
Susan Cleary, Novatek International
11:00- 11:30Plenary Q&A
11:30-12:30 Lunch
12:30-13:15Validation of Lyophilisation
for Parenterals
Kirstie Goggin, MTL Projects
13:15-14:00Equipment and Facility
design of an Aseptic Facility
Robert J. Hayes, SeerPharma (UK)
14:00-14:30Break/ Coffee & Tea
14:30-15:15Cleanroom and
Contamination Control S
15:15-16:00Plenary Q&A
16:30-18:00Snack and refreshments complimentary of
(Moderator): Laurence O’Leary, ValidEire ApS
08:45-09:20Breakfast and networking
09:20-09:30Intro to Day 2 by Moderator
09:30-10:15Media Fill studies
Gavin Ross, Founder, GTR Pharma
10:15-11:0Aseptic training with VR
Sebastian Scheler, CEO & Lead Psychologist,
11:00-11:30Plenary Q&A
11:30-12:30 Lunch
12:30-13:15Annex 1 &
Environmental monitoring
Matt Kite, Lighthouse Worldwide Solutions
13:15-14:00Temperature MappingValidation and Temperature Measurement
Enrique Riis, Ellab
14:00-14:30Networking break/ Coffee & Tea
14:30-15:30Processing and transfer of
primary packaging material for sterile
production and transfer to the filling line
Jana-Cathrien Müller, Atec Steritec GmbH
15:30-16:15Plenary Q&A all Speakers
16:15-16:25Wrap-up by Moderator
(Moderator): Pierre Devaux, Theraxel

Plenary Q&A

There will be opportunities on both days to engage with the speakers in Plenary Q&A.




Get in touch


Tlf: +45 6047 6819


ValidEire Aps
DK-4300 Holbæk
CVR number 39451573