Knowledge Management in GMP

17/18 September 2025, Hamburg, Germany

Course No. 22075

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Speakers

Aidan Madden

Aidan Madden

FivePharma

Arnoud Herremans

Arnoud Herremans

Lean Kaizen Consultant

Bertrand Dodelet

Bertrand Dodelet

UCB Biopharma SPRL, Belgium

Objectives

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.

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.

Target Group

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

Venue
Barceló Hotel Hamburg
Ferdinandstraße 15
20095 Hamburg
Germany
Phone: +49 (0) 40/22 63 62 0
E-Mail: hamburg.res@barcelo.com

Programme

Knowledge Management in GMP

Seminar Programme as PDF

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.

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

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This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more

ECA-Member*: € 1890,-
Non ECA Member*: € 2090,-
EU/GMP Inspectorates*: € 1045,-
APIC Member Discount*: € 1990,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

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Further dates on-site
Further dates on-site
Not available
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Further dates online
Further dates online
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Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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