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

Objectives

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.

Background

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

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
• 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.

Registration

 

Programme

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.

Key Note on 27 November: Trends & Challenges for the Development & Testing of Biotech Drug Products
Prof. Dr. Hanns-Christian Mahler, Chief Enablement Officer (CEO), ten23 health

Fortifying the Future: Advanced IT Security for Modern Labs
Joachim Post, wega Informatik

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

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

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

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

Automation of Environmental Monitoring Workflow
Adele Gisselmann, Merck

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

Transfer of Analytical Procedures. Practical Handling of Transfers to Different Types of CMO’s
Ulla Bondegaard, Novo Nordisk

Construction of a New Hazardous Materials Storage Facility for a Contract Laboratory
Dr Jochen Kolb, BioChem Labor für biologische und chemische Analytik

Lifecycle Management of Analytical Outsourcing
Erick Sjöberg, Eurofins

Regulatory Considerations for E&L Labs and Methods. From Pharmaceuticals to Medical Devices and in between - Combination Products
Dr Andreas Nixdorf, SGS INSTITUT FRESENIUS