Quality Culture - People Empowerment in GMP - Online Training Recording

Costs

*ECA-Member:**	EUR 1490,--
*Regular Fee:**	EUR 1690,--
*EU/GMP Inspectorates:**	EUR 845,--
*APIC Member Discount:**	EUR 1590,--

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

Registration

* also payable by credit card

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Objectives

This 2-day Live Online 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.

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.

Technical Details

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.

Training Course Documentation and Certificate:

The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

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

Case Studies: Which Quality Culture Options should be implemented in Business?

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

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?

Examples 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

Recording from 09/10.09.2021
Duration of the recording: approx. 10.5 h

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