Conference: Laboratory Optimization, Automation and Digitalization/Outsourcing in Pharmaceutical Laboratories
25/26 November 2025
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.
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.
Programme
Tuesday, 25 November 2025
KEYNOTE on 25 November 2025: Artificial
Intelligence in Pharmaceutical Industries
Dr Marcel Franke, Senior Scientist Predictive Formulation,
Process Solutions/Upstream & Process Materials R&D
Merck Life Science
From Spreadsheets and Paper to Digital Alternatives: Navigating Compliance, Reducing Errors, and Embracing Smarter Systems
Carsten Jasper, Jasper Consulting
- Description of typical data integrity and compliance risks associated with use of spreadsheets (based on a case study)
- Strategies to mitigate risks
- Proposal for an approach how decisions for selection of right solution can be made based on associated risks and benefit
Implementation of a LIMS - Lessons Learned
Dr Xaver Schratt, GBA Pharma
- Situation before Implementation
- Harmonization of Processes
- Standard-LIMS and necessary customization
- Timelines
- Main Contributors to Success
Achieving Cost Excellence in GMP Labs – A Proven Maturity Model for Sustainable Results
Dr Johann Gregori, Author & Speaker
- Maturity model that helps GMP laboratories evolve into continuously cost‑reducing organizations
- Digital processes, automation and organizational levers to deliver measurable impact
- Real‑life examples and roadmap to demonstrate how to achieve sustainable efficiency gains while maintaining GMP compliance
Beyond the Visible: Automating the Quest for Subvisible Particles in Parenteral Products by means of Microflow Imaging
Dr Melanie Zerulla-Wernitz, Vetter Pharma Fertigung
- Implementing an automated pipetting system for Microflow Imaging (MFI) testing
- Establishing a robust qualification and maintenance setup, including system suitability tests (SST) and regular requalification procedures
- Applicable consumables and their preparation
- Framework to develop, optimize, and qualify MFI methods tailored for new drug products
From Traditional QC to Real-Time Volume Control: Enhancing Screening Data Quality
Tobias Brode, Liquimetrix
- Overview of current QC practices in liquid handling and their limitations
- Introduction of a novel optical method for fast and precise volume measurement
- Practical examples for QC in multi-channel dispensing workflows
- Applications of inline/online volume verification
- Outlook: Towards closed-loop systems
QC-Automation: Development of a Fully Automated Bioburden Testing Solution
Anke Hossfeld, Merck Life Science
- Introduction to a Bioburden Automation Solution designed to streamline complex testing protocols
- Analysis of the need of the Pharma company for QC automation: benefits and challenges
- Advantages of a collaborative development approach
The Role of AI and Automation in Environmental Monitoring (EM): Driving Standardization, Efficiency, and Innovation in Microbiology
Arnalda Giambra, Copan Group
- Introducing an automation into the EM process to bring significant advantages in terms of efficiency, procedural standardization, and data integrity
- Workflow analysis to evaluate each phase of a typical EM process performed by trained personnel
- Comparison of manual operations with an automated workflow that included an incubator integrated with AI-based image analysis software for colony counting
From EM to Product Release: Transforming QC Labs with Connected EM Systems
Bernard Corcoran, Lonza
- How MODA-EM® System, when effectively integrated with rapid microbiological methods such as automated plate counters, rapid sterility/ bioburden systems, and the Pyrotec TM PRO can create seamless, unified digital workflow
- Real-world examples demonstrating how organizations have successfully leveraged integrated MODA-EM® solutions to streamline compliance, reduce risk, and improve overall throughput
Accelerate Journey towards Pharma 4.0 with Next Gen Lab Solutions
Rajasekhar Gollapinni, Caliber
- Leveraging Lab Automation to Fast-Track Pharma 4.0 Adoption
- Tackling Industry Challenges and Their Critical Impacts
- Revolutionizing QC Labs with Digital Workflows
- Seamless Integration of Lab Instruments for Optimal Efficiency
- Next-Gen Lab Solutions: Paving the Path to Pharma 4.0 Excellence
Wednesday, 26 November 2025
KEYNOTE on 26 November 2025: From Bog to
Bedside: Lessons from the First Dedicated Phage
Therapy Center in North America
Prof Dr Steffanie Strathdee, University of California San
Diego School of Medicine/Co-Director at the Center for
Innovative Phage Applications and Therapeutics
>> Find out more
Practical Examples on Digitalization, Optimization & Simplification in QC-Labs
Dr Karl-Heinz Bauer, Training - Beratung - Coaching
- Pitfalls to Automation & Digitalization in QC-Labs
- Challenges for an Instrument-Integration
- Use case 1: Digitalization – Connecting a balance to a LIMS
- Use case 2: Optimization – Improved HPLC installation for quick relocation
- Use case 3: Simplification – Strong workload reduction in QC-labs for Incoming Goods Testing
From Instrument to Knowledge: How to Organize the Digitalization of Your Laboratory?
Dr Steven van Helden, wega
- How to optimizing workflows, integrating instruments, making sense of the different software solutions, dealing with the IT department, ensuring lab security, FAIRification of data, coping with software updates and new developments
- How to build the bridge between science and IT to develop effective solutions for the lab
Future Labs: Architecture, Automation and AI
Kambiz Hajizadeh-Zaker, Vollack and Christian Ziegler, BAT
- How do existing and planned laboratory properties become future-proof?
- How can lab-architecture be developed envisioning future processes and utilizing users experience?
- How can architecture, process- and building-automation be connected and interact?
- Which role can AI play?
Smart Organization in the Laboratory: 47% Time Savings with 100% Precision
Mario Schneider, Better Basics Laborbedarf
- Smart workplace organization system to streamline laboratory operations by reducing process times
- Digital sample management tool to enhance precision by ensuring comprehensive and reproducible documentation of experiments
- Direction for the future of laboratory work
Standardization inside a Network of GMP Contract Laboratories
Dr Christoph Höppner, Eurofins BioPharma Product Testing Europe
- Client´s requirements, Pharmacopeial Standard and Local Expertise are Shaping Process and Output
- Retaining Flexibility & Countering Variability as guiding principles of Standardization
- Benefits of Standardization for the client´s Outsourcing activities – practical considerations
The Art of Partnership: Managing Expectations in Pharma-CRO Relationships
Malin Molander, Svar Life Science
- Enhancing communication and managing expectations
- Role of CROs in regulatory navigation
- Diverse expectations and urgent requests
- Defining responsibilities in agreements
- Internal alignment and regular communicatio
Microbial Qualification of Cleanrooms: Not Only CFU Counts - Big Projects in Different Spotlights
Alexander Pfülb, Labor LS
- Is Outsourcing a good idea for the Microbial Qualification of Cleanrooms?
- A Technical and Financial Deep Dive / What needs to be calculated?
- Balancing Precision and Budget