Conference: Laboratory Optimization, Automation and Digitalization/Outsourcing in Pharmaceutical Laboratories

Background & Objectives

The pressure that the pharmaceutical industry is under today to reduce costs and increase efficiency and effectiveness applies equally to analytical laboratories. Often, waiting for the results of quality control is still a speed-limiting step in the entire production process. With this conference, participants will get to know tools for more effective and efficient control of laboratory activities.

There are various reasons for outsourcing analytical testing. Tests are sometimes outsourced only for specific projects. However, the analyses are sometimes conducted externally for each batch of a product in routine quality control, for example, if the manufacturer does not have the necessary know-how or the required capacity.

You will be informed about:

• Optimization of laboratory processes
• Cost-efficient design of a laboratory
• Automation and optimization of environmental monitoring
• Case studies for laboratory automation/digitalization
• New analysis methods for the optimization of processes in the laboratory
• Tools to measure and monitor optimizations
• Practical aspects to consider when outsourcing activities
• Transfer of analytical procedures
• Practical aspects to consider when establishing contracts

Day 1 of this conference will show possibilities to optimize the organization of an analytical laboratory. The optimization of structures and processes in the laboratory will be addressed. Furthermore, the possibilities of automation will be presented, along with the benefits that can result from the optimization of the method portfolio. Modern approaches to cost savings while maintaining GMP compliance will also be presented.

Day 2 will highlight the wide range of regulatory requirements and practical aspects that need to be considered when testing on a contract basis or outsourcing activities. The conference particularly addresses topics that are relevant from a GMP point of view.

 

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Target Audience

This conference will be of significant value to Laboratory managers, supervisors and analysts, Quality control managers, Heads of quality control, Qualified Persons (QPs), Analytical scientists, Senior laboratory staff and responsible authorities

This conference is also intended for employees in Quality Assurance and from contract laboratories. Furthermore, it is useful for service providers, such as contract research organisations and contract manufacturers.

Moderation

Dr Karl-Heinz Bauer (Day 1)
Johannes Oberdörfer (Day 2)

Tuesday, 26 November 2024

Key Note on 26 November: The Promise and Challenges of In Vitro and In Silico Models in Drug Development
Dr Julia Schüler, Charles River Laboratories
The presentation will highlight important developments in the drug development technology landscape influenced by the concept of 3R and the evolving legal landscape. General characteristics of the different applications, their translational relevance as well as adoption drivers will be discussed. Case studies from oncology drug development will help to elucidate these trends and their impact on future processes.

Fortifying the Future: Advanced IT Security for Modern Labs
Rajiv Luthra, wega Informatik

• Critical IT security aspects in laboratories
• Informatics systems like LIMS, ELN, SDMS, LES, and CDS
• Importance of flexibility, configurability, and seamless data exchange
• Cybersecurity and measures include securing network gateways, malware prevention, and patch management
• Cloud-based LIMS applications, mobile device support, and intelligent data analysis integration

Potentials of an ERP Managed Logistic System for the Pharmaceutical Laboratory
Julia Abadir, VelaLabs

• Advantages of the inventory-managed purchasing strategy
• KPI and their potential for optimizing the material usage rate, lifecycle of goods, cost efficiency, etc.

Process Mapping and Redesign as the Basis for Laboratory Digitalisation
Dr Bob McDowall, R.D. McDowall Limited

• Understand and apply GMP regulations for electronic working
• Do not automate the status quo: map and redesign your process to work electronically
• Use informatics applications to drive digitalisation
• Case study examples of digitalisation projects

Sub-Visible Particulate Matter Testing – Reduce Variability in Blank Values with Automatization and Optimization – a Practical Case Study on Different Techniques
Dr Melanie Zerulla-Wernitz, Vetter Pharma Fertigung

• Procedure for blank value determination using light obscuration (LO) technique
• Implementation of an automated pipetting system was implemented for micro-flow imaging (MFI)
• Fully automated blank value determination for particle free containers

Foster Environmental Monitoring Results with Advanced Automated Systems
Laurent Leblanc, bioMérieux

• An overview of the challenges of the EM control
• The evolution of the regulatory context
• How important each elements of a fully automated EM solutions are to guarantee reliable results
• How the introduction of new incubation regimes, such as one media type with one temperature could be an opportunity to speed up the availability of EM data)

Automation of Environmental Monitoring Workflow
Adele Gisselmann, Merck

• Introduction of automated air sampling in cleanrooms with mobile robot
• Ready-to-use solution for traditional EM for fill and finish in gloveless isolators, improving traceability and safety
• Integration of automated plate reading solution in the EM workflow

Practical Examples of 5s Optimizations in Offices & QC-Labs
Dr Karl-Heinz Bauer, Boehringer Ingelheim

• Terms & Definitions
• Meaning & Advantages of 5S / KAIZEN
• Why 5S?
• Description of 5S in detail
• Practical examples and use cases of 5S