Aseptic Manufacturing – Maintaining the validated state

Conference description

This two-day intensive summit brings together the industry leaders in compliance, aseptic manufacturing and maintaining the validated state. The summit will go beyond presentations on best practice, and it 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 revised Annex 1, EMA focuses on inspecting sterile facilities, sterilisation, process validation, life cycle approach, and more. The summit will showcase some of the tech that impacts aseptic manufacturing.

In addition to the many presentations and workshops, the summit will also provide many opportunities for networking. Read more about the individual presentations in the full agenda.

The summit will be a physical event, but some speakers may participate virtually in case of unprecedented events.

Workshops and Exhibitors

As an extra value adding part of the summit workshops and exhibitors will be available in a separate room for both days exclusive to this summit.

Here you will be able to meet other participants, speakers and exhibitors all specifically focused on Aseptic Manufacturing disciplines.

Conference outline  (Full agenda →)

Day 1, TBD, Key2Compliance (Moderator)

• Registration and breakfast
• Intro to Day1 by Moderator
• EU Annex 1 – Manufacture of Sterile Medicinal Products – Pierre Devaux, Theraxel
• Pattern Recognition & Trending for Regulatory Compliance and Contamination Control Strategy – Susan Cleary, Novatek International
• Plenary Q&A
• Lunch / Exhibition open
• Sterilisation in Place and How to Validate – Luke Palmer, MTL Projects
• Understanding CPV – Robert J. Hayes, SeerPharma (UK)
• Break/ Coffee & Tea
• Cleanroom and Contamination Control Strategy – Pierre Devaux, Theraxel
• Plenary Q&A
• Workshops and Exhibitors
• Snack and refreshments – complimentary of   sponsors

Day 2, TBD, ValidEire ApS (Moderator)

• Breakfast and networking
• Intro to Day 2 by Moderator
• Annex 1 – Inspection Readiness – Magnus Jahnsson, Key2Compliance
• Aseptic training with VR –  Andreas Hablesreiter, Innerspace
• Plenary Q&A
• Lunch / Exhibition open
• Measurements, Mapping, Validation. Enrique Riis, Ellab
• Aseptic transfer possibilities of primary packaging material into an isolator or RABS systems regarding the updated Annex 1 – Jana-Cathrien Müller, Atec Steritec GmbH
• Networking break/ Coffee & Tea
• Plenary Q&A all Speakers
• Wrap-up

Summit objective

The objective of this summit is to provide participants with practical knowledge and understanding of regulatory requirements and techniques that can be used in their own aseptic manufacturing process strategy. The presenters will focus on the newest information available, and they will cover a wide range of subjects relevant to aseptic manufacturing and maintaining the validated state.

The summit is primarily relevant for R&D staff, Production Leaders, Supporters, Commissioning, Qualification & Validation teams and Quality Assurance. Anyone looking to exchange experiences and seeking the latest knowledge about risk- and cross contamination control, as well as engineering companies wanting to learn more about the viewpoints of the pharmaceutical industry.

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.

Summit venue, fees and facts

• The two-day summit will take place in Copenhagen, Denmark at DGI Byen Conference Center.
• The venue is right next to Copenhagen Central Station and only a few Metro-stops from Copenhagen Airport.
• Participation in the full program, including lunches and refreshments is 1495 Euros (excl. local VAT).
• Early bird price for signing up before 28^th of February 2023 is only 1295 Euros.
• Accommodation and travel are not included in the fee, however we will be happy to refer to hotels or travel agency support.
• Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the conference fee is invoiced in the local currency and local VAT is added.
• After the last session on Day 1 of the Summit, all attendees are invited to a networking get-together.
• The Summit takes place in cooperation between Key2Compliance and ValidEire ApS, and is sponsored by Novatek International and Steris.

Learn more about the Summit

INFORMATION AND AGENDA →     SPEAKERS AND PRESENTATIONS →

Agenda

Day 1
08:45-09:20 Registration, breakfast and networking
09:30-16:15 Conference
16:30-18:00 Workshops an Exhibition
18:00 . 19:30 Mingel
Day 2
08:45-09:20 Breakfast and networking
09:30-15.15 Conference

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