Dr Frank Seibel
Roche Diagnostics
Referent:innen
Dr Anke von Harpe
QProgress
Arnoud Herremans
Lean Kaizen Consultant
Christof Langer
OSConsulting
Cecilie Hejlskov
Syntese
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.
Date & Venue
Date
Thursday, 13 March 2025, 9.00h – 17.30h
(Registration and coffee 8.30h – 9.00h)
Friday, 14 March 2025, 8.30h – 14.45h
Thursday, 13 March 2025, 9.00h – 17.30h
(Registration and coffee 8.30h – 9.00h)
Friday, 14 March 2025, 8.30h – 14.45h
Venue
Barceló Sants Hotel
Plaça dels Països Catalans, s/n | 08014 Barcelona, Spain
Phone: +34 (93) 503 53 00
E-mail: sants@barcelo.com
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
Dieses Seminar/Webinar kann nicht gebucht werden. Alternative Termine für dieses Seminar/Webinar und ähnliche Veranstaltungen finden Sie in der Übersicht nach Thema..
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* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
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Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"
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Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Seminarprogramm als PDF
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