Aseptic Manufacturing – Maintain Validated State
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Aseptic Manufacturing – Maintain Validated State
June 14, 2022 @ 9:00 am - June 15, 2022 @ 4:30 pm
14th-15th June 2022 at DGI Byen, Copenhagen
A collaboration between Key2Compliance and ValidEire ApS
SUMMIT DESCRIPTION
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 OBJECTIVE
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.
AGENDA
| Day 1 – 14th June, 2022 | Day 2 – 15th June, 2022 |
| 08:45-09:20 Registration and breakfast | 08:45-09:20 Breakfast and networking |
| 09:20-09:30 Intro to Day1 by Moderator | 09:20-09:30 Intro to Day 2 by Moderator |
| 09:30-10:15 EU Annex 1 – Manufacture of Sterile Medicinal Products Pierre Devaux, Theraxel | 09:30-10:15 Compliance Updates for Media Fill Validation John Y.Lee |
| 10:15-11:00 Trending and Pattern Recognition as part of a Contamination Control Strategy Susan Cleary, Novatek International | 10:15-11:00 Aseptic training with VR Andreas Hablesreiter, Innerspace |
| 11:00- 11:30 Plenary Q&A | 11:00-11:30 Plenary Q&A |
| 11:30-12:30 Lunch | 11:30-12:30 Lunch |
| 12:30-13:15 Validation of Lyophilisation for Parenterals Kirstie Goggin, MTL Projects | 12:30-13:15 Annex 1 & Environmental monitoring Matt Kite, Lighthouse Worldwide Solutions |
| 13:15-14:00 Equipment and Facility design of an Aseptic Facility Robert J. Hayes, SeerPharma (UK) | 13:15-14:00 Temperature Mapping- Validation and Temperature Measurement Enrique Riis, Ellab |
| 14:00-14:30 Break/ Coffee & Tea | 14:00-14:30 Networking break/ Coffee & Tea |
| 14:30-15:15 Cleanroom and Contamination Control Strategy Pierre Devaux, Theraxel |
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 |
| 15:15-16:00 Plenary Q&A | 15:30-16:15 Plenary Q&A all Speakers |
| 16:00-16:15 Wrap-up | 16:15-16:25 Wrap-up by Moderator |
| 16:30-18:00 Snack and refreshments-complimentary of |
SPEAKERS
John Y. Lee, |
Pierre Devaux, |
Kirstie Goggin, |
Robert J Hayes |
Andreas Hablesreiter, |
Matt Kit |
Susan B. Cleary, B.CS, M.B.A. |
Enrique Riis, |
Jana-Cathrien Müller, |
Lars- Eric Ellow, |
SPONSORS
ARRANGED BY
