Managers and Executives from pharmaceutical Quality Management and Assurance, Business Executives and Production Managers and those involved in continuous improvement projects.
Objectives
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.
Programme
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 Exercises 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
Linking Lean and Quality
Discussion of various case studies
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
Further Information
Venue DoubleTree by Hilton Berlin Ku´Damm Los-Angeles-Platz 1 10789 Berlin, Germany Phone: +49 (0) 30 2127 714 alexander.kliche@eventhotels.com
Accommodation
CONCEPT has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/ POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Social Event On 25 March you are cordially invited to a social event (city tour and dinner). This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Fees (per delegate, plus VAT) ECA Members EUR 1,890.- APIC Members EUR 1,990.- (does not include ECA Membership) Non-ECA Members EUR 2,090.- EU GMP Inspectorates EUR 1,045.- The conference fee is payable in advance after receipt of invoice and includes lunch on both days and all refreshments. VAT is reclaimable.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Testimonials
