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Opening & Welcome Message (15:00-18:00 SGT | 08:00-11:00 BST | 09:00-12:00 CET)
Bruce Loxley (Moderator)Siegfried Schmitt (Moderator)
  • Bruce Loxley (Moderator) (Senior GMP Compliance Advisor at GlaxoSmithKline Vaccines)

    Bruce Loxley (Moderator)

    Senior GMP Compliance Advisor at GlaxoSmithKline Vaccines
  • Siegfried Schmitt (Moderator) (Vice President, Regulatory & Access at Parexel)

    Siegfried Schmitt (Moderator)

    Vice President, Regulatory & Access at Parexel
MES for the Future
Sinéad CowmanThomas Halfmann

During this presentation we will discuss why the approach to MES needs to change.

- What are the challenges that the industry needs to overcome to make MES accessible for small to midsized companies and especially for modalities such as cell therapy.
- Lonza’s approach to digitalize their Cell Therapy manufacturing.
- How implementation can be accelerated to help companies achieve their digitalization vision

  • Sinéad Cowman (Global Business Development & Marketing Manager – Informatics at Lonza)

    Sinéad Cowman

    Global Business Development & Marketing Manager – Informatics at Lonza
  • Thomas Halfmann (Director, Global Head Production & Laboratory of NNIT)

    Thomas Halfmann

    Director, Global Head Production & Laboratory of NNIT
Automated Environmental Monitoring: The solution for the next decade
Niels Visschers

ABSTRACT OVERVIEW
Microbiological environmental monitoring using agar plates is labour intensive, lasting up to seven days to obtain and report results. Additionally, given the number of manual steps involved in the process, it can be considered as a source of error for Data Integrity.

In this presentation, we will describe the work performed to determine the suitability for use of a high-volume incubator/reader systems for environmental monitoring. Our results demonstrate a better performance of the systems for colony detection than specialized analysts. Additionally, results were obtained within 4 days. Faster results mean an earlier alert of critical samples that exceed their limits; actions can be taken sooner and significant benefits such as faster investigations/batch release can be realised.

Such automation leads to a secure paperless workflow right from the sampling plan to the final result being reported. Barcoded supplies ensure full traceability of the process and the ability to locate a sample at any point of its life in the facility and high-quality images of each plate are readily available for view during and at the end of incubation, as well as for retrieval once the results have been archived. Altogether, this significantly improves the compliance levels towards Data Integrity.

ABSTRACT OBJECTIVE
The objective of to present results from development studies with automatic incubator/colony readers that support the suitability for use of these systems for Environmental Monitoring.

AUDIENCE TAKE-HOME BENEFITS
With the Implementation of automated colony counters, results can be obtained within 3-4 days. Consequently, corrective actions can be taken sooner, and significant benefits can be realised. Moreover, productivity increase by reducing touch times on transporting plates, reading-out plates and transmitting results into a Lims system. Early warnings are sent when samples are exceeding their limit. Automatization develops a secured paperless workflow from the point of sampling to the final record, increasing the reliability by ensuring a seamless integration process in compliance with Data Integrity.

  • Niels Visschers (Specialist Microbiology at Merck)

    Niels Visschers

    Specialist Microbiology at Merck
Industry 4.0 and Regulatory Challenges
Mark Birse

This session will look at examples of Industry 4.0 technologies being developed today and how regulators need to adapt. It will explore where regulators fit into the innovation space, the challenges they face in a rapidly changing environment and what changes could be made to the regulatory landscape.

  • Mark Birse (Vice President, Technical at Parexel)

    Mark Birse

    Vice President, Technical at Parexel
Live Q&A
Mark BirseSinéad CowmanThomas HalfmannBruce Loxley (Moderator)Siegfried Schmitt (Moderator)Niels Visschers
  • Mark Birse (Vice President, Technical at Parexel)

    Mark Birse

    Vice President, Technical at Parexel
  • Sinéad Cowman (Global Business Development & Marketing Manager – Informatics at Lonza)

    Sinéad Cowman

    Global Business Development & Marketing Manager – Informatics at Lonza
  • Thomas Halfmann (Director, Global Head Production & Laboratory of NNIT)

    Thomas Halfmann

    Director, Global Head Production & Laboratory of NNIT
  • Bruce Loxley (Moderator) (Senior GMP Compliance Advisor at GlaxoSmithKline Vaccines)

    Bruce Loxley (Moderator)

    Senior GMP Compliance Advisor at GlaxoSmithKline Vaccines
  • Siegfried Schmitt (Moderator) (Vice President, Regulatory & Access at Parexel)

    Siegfried Schmitt (Moderator)

    Vice President, Regulatory & Access at Parexel
  • Niels Visschers (Specialist Microbiology at Merck)

    Niels Visschers

    Specialist Microbiology at Merck