Dr Anke von Harpe
QProgress
Referent:innen
Cecilie Hejlskov
Syntese
Arnoud Herremans
Lean Kaizen Consultant
Dr Frank Seibel
Roche Diagnostics
Christof Langer
OSConsulting
Zielsetzung
Learn how to design lean, efficient and compliant Quality and GMP-Systems that will support you in turning your quality goals into reality.
Hintergrund
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.
Zielgruppe
Managers and Executives from pharmaceutical Quality Management and Assurance, Business Executives and Production Managers and those involved in continuous improvement projects.
Programm
Gesamtes Programm als PDF herunterladen
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.
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
| ECA-Member*: | € 1690,- |
| Non ECA Member*: | € 1890,- |
| EU/GMP Inspectorates*: | € 945,- |
| APIC Member Discount*: | € 1790,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Für Lieferanten: Ausstellungs- und Sponsoringmöglichkeiten
Seminarprogramm als PDF
Sonderkonditionen DB BahnTeilnehmerstimmen - das sagen andere über unsere Seminare:
