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 underperforming 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