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