Quality Culture - Personal Empowerment in GMP

Quality Culture - Personal Empowerment in GMP

Prague, Czech Republic

Course No 17533

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Speakers

Stephan Dresen, Corden Pharma, Germany
Aidan Madden, FivePharma, Ireland
Dr Daniel Marquardt,Boehringer Ingelheim, Germany
Kristina Smith Hansen, MilCor Consulting, Denmark
Francois Vandeweyer, VDWcGMP Consulting, Belgium

Objectives

This 2-day Master Class 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.

Background

“Vision without execution is hallucination” – Thomas Edison

More than ever, quality culture in pharmaceutical industry is coming to the fore. Industry leaders recognise that it is essential for ensuring high quality processes and products. Establishing and maintaining a good quality culture seems to be a key to continuous improvement and business continuity. Regulatory authorities also emphasise the importance of continuous improvement of processes and quality. A lived vital culture from the shop floor to upper management is indispensable here.

But it needs to be more than just a vision! A good quality culture is based on the behaviour of the individuals within the corporate quality strategy and the appropriate infrastructure of the company. It is important that everybody is aware of the importance of quality. Individuals need to transfer both knowledge and quality values. This vision must be executed. How this can be done will presented and discussed in this Master Class.

Target Group

Managers and Executives from pharmaceutical Quality Assurance and Quality Management but also Business Executives and Production Managers and those involved in Quality Culture initiatives.

Programme

What is Quality Culture?
  •  Why the focus on Quality Culture?
  •  Why is it important?
  •  Who creates culture and how?
  •  Core elements
    •  Leadership at the top
    •  Confidence in the part of all employees
    •  Clear management visibility and leadership
    •  Accountability at all levels
    •  Sharing of knowledge and information
    •  Best practices
  •  Before you improve the Quality Culture
    •  Understand why changing culture is hard
    •  What must be influenced to see desirable changes
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
Workshop:
  • Which Quality Culture Options should be implemented in Business?
Knowledge Management and Knowledge Structuring
  •  Principles – definition and segregation
  •  Knowledge Management as part of Quality Culture
  •  From content to knowledge: structuring of knowledge
  •  Semantic Web: Ontology vs. Topic Map
  •  Relationship models and retrieval - how does knowledge become available
  •  Knowledge Management and Data Integrity
  •  How do I keep knowledge up-to-date? Knowledge Management Systems (KMS) vs. Data Warehouse
  •  Practice example: How can I store and preserve knowledge in a structured storage format?
Case Study: Boehringer Ingelheim’s Quality Culture Initiative
  •  Cultural enablement as a foundation for CQI und Business Continuity
  •  Quality Culture at BI: From initiative introduction to operationalisation
  •  Dimensions of cultural excellence framework
  •  Is Quality Culture measurable?
Interactive Sessions on:
Quality Control Laboratory
Production Environment
  •  Indicate/identify “bad” quality culture behaviours
  •  How to get to a better quality culture (how to create new behaviour)
  •  What will happen if we do not take the right action
  •  Set up appropriate KPIs
 Techniques to evaluate Quality Performance
  •  Process Analysis
  •  Root Cause Analysis
  •  Cause-and-Effect Diagrams
  •  Risk Assessment
  •  Quality Cockpit
  •  KPIs
  •  Tracking & Trending
Error culture as part of Quality Culture
  •  Definitions
  •  How mistakes / errors become disasters
  •  Root Causes (Deep Dives) - symptoms and effects
  •  Good error culture: from error to success
  •  Errors and mistakes in the workspace: practical examples
  •  Role of the executive management - dealing with mistakes
  •  Tools from the OPEX toolbox
  •  Cooperation instead of confrontation
  •  The toddler rule: action must have consequences
  •  The team spirit
A Behavior-Based Continuous Improvement Model
  •  Creating Quality Culture performance expectations
  •  Educating and training to influence behavior
  •  Communicating Quality Culture effectively
  •  Developing Quality Culture goals and measurements
  •  Using consequences to increase or decrease behaviors
  •  Encourage & energize the team

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