Aseptic Manufacturing – Maintaining the validated state

ONLINE or LIVE Conference

A collaboration between:
Key2Compliance® and VALIDEIRE

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.

Conference outline

Day 1, October 21^st
Moderator: Laurence O’Leary, ValidEire Aps

• Intro to Day 1 by Moderator
• EU Annex 1- Manufacture of Sterile Medicinal Products
  Pierre Devaux, Theraxel
• System Real Time Data Integrity, Electronic Sample Collection in Controlled Areas.
  Susan Cleary, Novatek International
• Plenary Q&A
• Equipment Sterilisation for Aseptic Manufacturing
  Josh Thompson, 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, October 22^nd
Moderator: Pierre Devaux, Theraxel

• Intro to Day 2 by Moderator
• Media Fill studies
  Gavin Ross, Founder, GTR Pharma
• Aseptic training with VR
  Sebastian Scheler, CEO & Lead Psychologist, 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 objectives

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.

Who should attend

This course is intended for:

• Team Leaders and Management within Quality Assurance and/or Production/Product Supply
• Specialists, Professionals, and/or Project Managers responsible for change management, strategic operation, stakeholder management, training and/or global communication
• Internal/External Lead Auditors
• Team Leaders and Management within Regulatory Affairs and Research and Development should also attend
• Risk management personnel, Compliance, and/or Health and Safety specialists

Conference model

We have created a conference model that accommodates the best experience for all attendees in the current global Covid-19 situation. We hope to facilitate for more attendees and the conference price also is reduced significantly to open up for a wider audience.

Presentations (Pre-recorded Sessions)

All presentations will be pre-recorded in September 2020 as speakers’ local time zones will not be optimal for presenting with local times in central European time (CET) when the event is hosted. These will however be broadcast at the times displayed in the table and available prior and after the conference to view at no further cost.

Plenary Q&A (Live Sessions)

The speakers will be present in real time and available to answer questions either relayed beforehand by mail or live at the plenary Q&A. These will be broadcast at the times displayed in the table and be available after the conference to view at no further cost.

Workshops (Live Sessions)

The workshops also will be in real-time and dual communication between the facilitator and attendees will be possible either through a chat function or via microphone managed by the moderator. These will be broadcast at the times displayed in the table and be available after the conference at no further cost.

#5255