How Lean Thinking supports our GMP Status (Basic Lean SixSigma Tools)
- Background and definitions:
- Lean thinking
- Customer value
- Continuous improvement
- Waste (in a process)
- Fundamental problem-solving tools used to support Lean Six Sigma and other process improvement efforts
Parallel sessions (2 out of 3):
1. APIs: How to use Risk Assessment and Criticality Analyses to improve Quality Processes
- How to develop syntheses and process criticality analyses and use the benefit in:
- Lean deviation handling
- Lean batch record review
- Lean release process
2. Lean and SixSigma Tools and how to apply them
- Learn and discuss how to implement and use the most important Lean SixSigma tools.
3. Efficient Data Pooling: KPIs, PQR, APR, Management Review
- How to define meaningful KPIs?
- What are useful KPIs?
- What risks are involved using KPIs?
- How to drive the development of an nderperforming Quality System
You will be able to attend 2 of these sessions.Please choose the ones you like to attend when you register for the course.
Linking Lean and Quality
Discussion of various case studies in two interactive sessions, for example:
- Use historic data
- Get out of a mess
- Make use of a network
Lean (Documentation) Systems
- Tools and structural elements for efficient GMP documents
- Training – how to ensure the right level for each role
- Case study: Batch Record Review to the point
Kaizen as a Powerful Tool for Optimisation of complex Processes
- Does the system fit to the company?
- Methods for determining needs and finding solutions
- Customer-oriented project planning as a central success factor
Using LEAN Thinking for Improvements in the Quality Management System (QMS)
- Experiences in using LEAN/Six sigma methodology for QMS improvements
- Examples of process simplifications
- Deep dive in creating a LEAN CAPA process
Optimisation of the Ferring Supply Process and EU Hub Release
- Process analysis
- Improvement actions
- Evaluating and Monitoring Effectiveness