Dr Anke von Harpe
QProgress
Referent:innen
Cecilie Hejlskov
Ferring
Arnoud Herremans
Lean Kaizen Consultant
Dr Frank Seibel
Roche Diagnostics
Christof Langer
OSConsulting
Compliance – Efficiency – Quality
Zielgruppe
Managers and Executives from pharmaceutical Quality Management and Assurance, Business Executives and Production Managers and those involved in continuous improvement projects.
Zielsetzung
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.
Programm
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 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
Weitere Informationen
Venue
DoubleTree by Hilton Berlin Ku´Damm
Los-Angeles-Platz 1
10789 Berlin, Germany
Phone: +49 (0) 30 2127 714
alexander.kliche@eventhotels.com
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.
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.
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.
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.
Contact
Questions regarding content:
Mr Wolfgang Schmitt, +49 (0) 6221 84 44 39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Julia Grimmer, +49 (0) 6221 84 44 44, julia.grimmer@concept-heidelberg.de
Mr Wolfgang Schmitt, +49 (0) 6221 84 44 39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Julia Grimmer, +49 (0) 6221 84 44 44, julia.grimmer@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 25 March 2026, 9-17:30 h
Thu, 26 March 2026, 8-15:30 h
Thu, 26 March 2026, 8-15:30 h
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine 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
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