Aidan Madden
FivePharma
Referent:innen
Arnoud Herremans
Lean Kaizen Consultant
Bertrand Dodelet
UCB Biopharma SPRL, Belgium
Zielgruppe
Managers and Executives from pharmaceutical Quality Management but also Business Executives and Operational Managers and those involved in KM initiatives.
Zielsetzung
This 2-day Live Online 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.
Background
“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.
Programm
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
Examples:
Identifying critical Knowledge Areas
This session 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
This session 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
Weitere Informationen
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Contacts
Questions regarding content:
Mr Wolfgang Schmitt, +49 (0)6221 84 44 39, w.schmitt@concept-heidelberg.de
Questions regarding Organisation:
Mr Ronny Strohwald, +49 (0)6221 84 44 51, strohwald@concept-heidelberg.de
Recording from 18/19 September 2025
Duration of the recording: approx. 09 h 20 min
Duration of the recording: approx. 09 h 20 min
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Regular Fee*: | € 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"
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E-Mail: info@concept-heidelberg.de
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