Learn how to design lean, efficient and compliant Quality and GMP-Systems that will support you in turning your quality goals into reality.
Background
Good Manufacturing Practices (GMP) in the pharmaceutical industry are designed to ensure that products are consistently produced and controlled according to defined quality standards. However, some companies tend to overinterpret regulations, leading to unnecessary processes that can inflate costs and reduce efficiency. To right-size GMP and compliance, and move towards lean GMP-systems while still adhering to regulations and being compliant, companies can consider several strategies and use various tools. By focusing on these, companies can develop lean GMP-systems that are not only compliant but also optimised for efficiency and effectiveness. It's about finding the right balance between ensuring product quality and safety while eliminating unnecessary costs and processes.
Target Group
Managers and Executives from pharmaceutical Quality Management and Assurance, Business Executives and Production Managers and those involved in continuous improvement projects.
Less is more: Insights from continuous Improvement to bring GMP to the Size you need
What does lean thinking mean (and what does non-lean thinking mean)?
Role of Quality functions
Customer value
Examples for problem solving Tools
Continuous improvement
Lean Process Management: Case Studies & Template Tools
PfC Analysis
Process Competent Assessment
Effectiveness Check
Templates
Linking Lean and Quality
Using Lean Thinking for Improvements in the Quality Management System (QMS)
Potential Target Areas of Lean
QC Backlog - Timely deviation closure - Batch Record Review - “Non Make/Assess/Release”- Areas - Lean leadership
Interactive Sessions:
Coaching and Mentoring your People towards better GMP Improvements Learn and discuss the A3 lean thinking approach as a learning practice, problem solving tool and knowledge sharing.
Lean Process Management: Workshop with Theory and Group Excersises Learn to manage your quality processes in a practical and lean way through an interactive workshop with theory and group exercises.
Right-sizing GMP and Compliance
The ‘What’ vs the ‘How’ - what is the right ratio?
How to apply ‘Ensuring’ and ‘Controlling’ in a balanced manner
The ‘7 deadly sins’ of right-sized compliance
Ways to implement
Lean (Documentation) Systems
Background
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
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more
Testimonials
Seminar Programme as PDF