Date:
June 7-11, 2021
Venue:
Language:
Online - Click here to register.
The block course takes place in German.
Summary:
Managing a laboratory requires the coordination of a large number of activities and is associated with a high level of responsibility. Not only must processes, projects, employees, time and resources be coordinated, but quality must also be guaranteed and costs kept under control. To be able to cope with all these tasks and requirements, a laboratory manager needs various instruments and tools that they must be able to use confidently to make managing the laboratory easier. During the block course, participants will learn how to use these tools and how to use them in practice. The focus is on the areas of quality management, project management, occupational safety, LIMS and controlling as well as on the soft skills of communication, leadership and motivation.
Learn more about the event here.
Program:
10:00 a.m. - Laboratory organization and processes
- Thinking in processes
- Digitize processes
- Workflow optimization
- Uncover optimization potential
10:45 a.m. - Computer science in the lab
- What Is a LIMS?
- What does a LIMS offer?
- What benefits can be expected?
- Further terms ELN, LES, CDS
- Document management systems DMS
11:30 a.m. - Coffee break Coffee break
12:00 p.m. - Basic modules of a LIMS
- Sample receipt and sample registration
- Determining the scope of the investigation
- Support for sample distribution and processing
- Results data acquisition
- Calculation of results or limit value tests
- Release of the test results
- Reporting and evaluations
12:45 p.m. - Regulatory requirements
- Influence on processes
- IT support for compliance with regulatory requirements
- 21 CFR Part 11, Data Integrity, Audit Trail (Review)
- User identification
- Different types of electronic signature
13:30 - Lunch break Lunch break
14:30 - Device connection
- Approaches and possibilities, advantages and disadvantages
- Data integrity
- The importance of data and communication standards
4:00 p.m. - Coffee break Coffee break
16:30 - How do you find the best LIMS for your lab?
- Process analysis and optimization
- Specifications
- Provider overview
- Invitation to Tender
- Meaning of leadership: influence, goal orientation
- Tasks of a manager
- Rights and duties of a manager
- Lateral leadership in projects and networks
- Leadership in hierarchical organizations
- Ambidextrous guidance
- Rewards and incentives
- Objectives, requirements and sanctions
- Communication as a central management tool
- Effectiveness as a central characteristic of leadership
- Importance for managers - necessity of self-management
- Motivation for leadership
09:00 a.m. - Business management basics and the laboratory
- Operational goals
- Operating figures
- Instruments and functions of business administration for the laboratory
- Classification of the laboratory in the system of business administration
- Information supply in the laboratory
- Planning
- Control
- Control system
- Cost element accounting
- Cost center accounting
- Cost unit accounting
- Financial key figures
- Key performance indicators
- Marketing & sales key figures
- Vision & Strategy
- Perspectives
- Goals - measures - key figures
- DIN EN ISO 9001, DIN EN ISO/IEC 17025, GLP and GMP
Similarities and differences in the legally regulated and standardized areas
Which QM/QA system is suitable for my laboratory, what do I need to consider?
- Basics of DIN EN ISO 9001:2015; standard requirements
- Continuation from part I
- Basics of DIN EN ISO/IEC 17025:2018; standard requirements
- Tools for: Assessment of impartiality, assessment of the organization's environment, action management
- Risk and opportunities
- Identification, assessment, action planning and evaluation of effectiveness
14:30 - Requirements of ISO 45001 in the context of DIN EN ISO 9001 (Boderius)
- Integrated management approach with occupational health and safety and quality management
- Similarities and differences between the two sets of rules
3:15 p.m. - Coffee break Coffee break
15:45 - Occupational health and safety management and legal requirements (Boderius)
- Introduction, origin
- What does the legislator require?
- Role of the employers' liability insurance associations
16:30 - Implementation of an occupational health and safety concept (Boderius)
- Roles and functions in occupational health and safety, occupational health and safety committee (ASA),
- Risk assessment
- Operating instructions for the laboratory
- Instruction
- Safety inspection / occupational health and safety inspections (audits)
- Monitoring of measures
- Development aid for occupational health and safety management systems
08:30 a.m. - Basic knowledge of projects
- Project term
- Special requirements for project managers
- Phases of projects
- Preparation for the start of the project
- Create project order
- Focusing the project and defining project content
- Plan milestones
- Identify required skills within the project
- Analyze stakeholders
- Organize collaboration and data storage
- Prepare and carry out project kickoff
- Defining rules for cooperation
- Structuring the project and creating a project plan
- Determine project organization
- Plan and carry out status reports
- Project controlling
- Action planning
- Monitoring the implementation of measures
- Accompanying change
- Dealing with changes
- Preparing the handover of responsibility
- Review of target achievement
- Create project documentation
- Carry out project completion
- Implement lessons learned
The Speakers:
Daniel Juchli
Managing Director and Head of Lab & Research Informatics at wega Informatik AG and Chief Technical Officer in the SiLA Consortium.
Thanks to his dual qualification as a chemist and IT expert, he can draw on over 20 years of professional experience. His life science knowledge enables him to build bridges between the needs of users and the technical possibilities of IT systems and to act as a translator between scientists and IT experts.
He leads projects to build laboratory automation and IT solutions in life science environments, such as research and development labs or QC labs in regulated environments. Since 2014, he has been significantly involved in the development of SiLA 2.
... and many other speakers, find out more here.