Speakers

Aidan Madden

Aidan Madden

FivePharma

Arnoud Herremans

Arnoud Herremans

Lean Kaizen Consultant

Edel Ryan

Edel Ryan

Bristol-Myers Squibb

Bothaina Attia

Bothaina Attia

Ferring

Thaleia Aikaterini Darmi

Thaleia Aikaterini Darmi

Boehringer Ingelheim Hellas

Highlights:
- How to implement Quality Culture in Business
- Knowledge Management
- Error Culture and Human Behaviour


Target Group

  • Managers and Executives from pharmaceutical Quality Assurance and Quality Management
  • Business Executives and Production Managers involved in Quality Culture initiatives

Objectives

This 2-day Training brings together well-experienced experts to explain and discuss the latest developments and expectations on Quality Culture and how Quality Culture is linked to human behaviour and continuous improvement. This will support you turning your company’s quality excellence goals into reality.


Programme

What is Quality Culture?
  • Why the focus on Quality Culture? is it important?
  • Who creates culture and how?
  • Core elements
Developing a Quality Culture; why is EU GMP Volume 4 Chapters 1-9 the wrong Place to start?
  • How does EU-GMP promote a Quality Culture?
  • What kind of Quality Culture does Chapter 1 promote?
  • Where can we look to for better Quality Culture Guidance?
  • Looking to the great Quality Culture proponents (ISO 9001, Deming, Motorola, Toyota) for inspiration
Knowledge Management as part of Quality Culture
  • Principles – definition and segregation
  • From content to knowledge: structuring of knowledge
  • Relationship models and retrieval - how does knowledge become available
  • How do I keep knowledge up-to-date? Knowledge Management Systems (KMS) vs. Data Warehouse
Workshop: Which Quality Culture Options should be implemented in Business?
Discuss how different Quality Culture ‘Ingredients’ would fit into the business you are in and specifically how the Quality Unit would incorporate them into their existing systems.

Error Culture as part of Quality Culture
  • Error Culture – what do we mean by that?
  • Factors that effect openness
  • Error Management
  • Errors and stress
  • Creating an Error Management Culture
Case Studies
  • Boehringer Ingelheim
  • Ferring
  • BMS
What triggered the initiative, how was Quality Culture implemented, how is it measured and evaluated, lessons learned, benefits, how can Quality Culture be maintained and further developed.


Further Information

Venue
Barceló Hotel Hamburg
Ferdinandstrasse 15
20095 Hamburg
Germany
+49 40 22 63 62-0
hamburg.res@barcelo.com 

Accommodation
CONCEPT HEIDELBERG 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 3 November you are cordially invited to a social event. 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
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 conference documentation, dinner on the first day, 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.

Conference language
The official conference language will be English.

Contacts
For questions regarding content:
Mr Wolfgang Schmitt, +49 6221 84 44-39, w.schmitt@concept-heidelberg.de
For questions regarding organisation:
Mr Niklaus Thiel, +49 6221 84 44-43, thiel@concept-heidelberg.de


Date & Time

Tue, 3 Nov 2026, 09:30-17:00 h
(Registration 09:00-09:30 h)
Wed, 4 Nov 2026, 08:30-15:30h

Costs

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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Additional dates on-site
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Recording
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This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"

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