Aidan Madden
FivePharma
Referent:innen
Arnoud Herremans
Lean Kaizen Consultant
Bertrand Dodelet
UCB Biopharma SPRL, Belgium
Zielsetzung
This 2-day Training brings together well-experienced experts to explain and discuss the basics, developments and expectations on Knowledge Management and why it is so important throughout the business. This will support you turning your company’s operational excellence goals into reality.
- Get a comprehensive understanding of knowledge management (KM)
- Discuss tools and strategies to develop and implement effective KM frameworks in their organizations
- Hear about practical applications of KM to enhance compliance, quality, and operational efficiency
Whether you are just starting your KM journey or looking to enhance existing practices, this event offers valuable insights for professionals at all levels.
Hintergrund
“Knowledge management will never work until corporations realise it's not about how you capture knowledge but how you create and leverage it.” – Étienne Wenger
Knowledge management has become an important cornerstone in industry practices, also in pharma, particularly with the increasing complexity of processes and stricter regulatory requirements. Efficient knowledge creation, transfer, and application are essential for maintaining compliance, minimizing mistakes and risks, eliminating waste of time and driving innovation. This course delves into the "what," "why," and "how" of KM in GMP, providing attendees with actionable insights to strengthen their systems and ensure long-term success in a competitive industry.
Knowledge management has become an important cornerstone in industry practices, also in pharma, particularly with the increasing complexity of processes and stricter regulatory requirements. Efficient knowledge creation, transfer, and application are essential for maintaining compliance, minimizing mistakes and risks, eliminating waste of time and driving innovation. This course delves into the "what," "why," and "how" of KM in GMP, providing attendees with actionable insights to strengthen their systems and ensure long-term success in a competitive industry.
Zielgruppe
Managers and Executives from pharmaceutical Quality Management but also Business Executives and Operational Managers and those involved in KM initiatives.
Date & Venue
Date
Wednesday, 17 September 2025, 9.30h – 17.30h
(Registration and coffee 9.00 – 9.30 h)
Thursday, 18 September 2025, 8.30h – 15.30h
Wednesday, 17 September 2025, 9.30h – 17.30h
(Registration and coffee 9.00 – 9.30 h)
Thursday, 18 September 2025, 8.30h – 15.30h
Venue
Barceló Hotel Hamburg
Ferdinandstraße 15
20095 Hamburg
Germany
Phone: +49 (0) 40/22 63 62 0
E-Mail: hamburg.res@barcelo.com
Programm
Gesamtes Programm als PDF herunterladen
Knowledge Management in GMP
- Examples of Knowledge Management requirements
- Examples from other industries and within pharma
- ISO 30401 and what pharma can learn from this Standard
- ICH Q8, Q9 and Q10 Questions & Answers Document
- Impact on compliance, efficiency, and Quality
- Tying KM to CAPA, change management, and Quality Systems
- KM and QRM, opposing forces or essential partners?
- The Ontology Pipeline
Building a Knowledge Management Framework in GMP
- Part 1
- Core components: people, processes and technology. How they interact and reinforce each other.
- Tools for knowledge management (A3, fishbone, process mapping) - Part 2
- Steps to develop and implement a Knowledge Management System
- Ensuring your KM arrangements are compliant with Inspectors expectations (EU GMP Volume 4 Annex 11, CFR Part 11, GAMP 5)
- Exploring the Risk-Knowledge Infinity Cycle (RKI Cycle) across the Product Lifecycle
Workshops:
Identifying critical Knowledge Areas
The workshop is based around a manufacturing process of a complex biotech product, problems have arisen in the manufacturing process and the task of the participants is to assess the problems and to identify where the application of KM would have prevented the problems arising.
Identifying critical Knowledge Areas
The workshop is based around a manufacturing process of a complex biotech product, problems have arisen in the manufacturing process and the task of the participants is to assess the problems and to identify where the application of KM would have prevented the problems arising.
What goes in? Stimulation of the Creation of new Knowledge (Creating a Knowledge Sharing Culture)
- Continuous improvement - radical Innovation
- Breakthrough innovation, removing barriers in our thinking
Smart GMP: How Knowledge Management drives Operational Excellence
- Role of standards, SOP’s and work instructions as Knowledge carriers
- Making knowledge available at point of use
Case Study UCB: Strategies for Knowledge Transfer
- Where do we come from?
- Where are we now?
- Where do we want go?
- Lessons learned, the use of databases, IT-platforms and other tools
| 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
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
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