Aseptic Manufacturing – Maintaining the validated state

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Language : English
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description

Sponsored by
Novatek International

 

Conference 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.

Key Note Speaker

Mr John Y. Lee
Mr John Y. Lee
Pharmaceutical Compliance Associates

Conference outline

Download the full agenda with speaker presentations (updated May 17, 2022) →

Day 1
Moderator: Lars Eric-Ellow, Key2Compliance AB

  • Intro to Day 1 by Moderator
  • EU Annex 1- Manufacture of Sterile Medicinal Products
    Pierre Devaux, Theraxel
  • Trending and Pattern Recognition as part of a Contamination Control Strategy
    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
Moderator: Lars Eric-Ellow, Key2Compliance AB

  • Intro to Day 2 by Moderator
  • Compliance Updates for Media Fill Validation
    John Y. Lee, Pharmaceutical Compliance Associates
  • Aseptic training with VR
    Andreas Hablesreiter, 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 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.

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.

Agenda

Day 1
08:45-09:20 Registration, breakfast and networking
09:30-16:15 Conference
16:30-18:00 Networking, mingling and snacks (compliments of sponsor)
Day 2
08:45-09:20 Breakfast and networking
09:30-15.45 Conference

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