Arnoud Herremans
Lean Kaizen Consultant
Referierende
Henny Koch
Qimp
Dorthe Christina Kroun
MinervaX
Cecilie Hejlskov
Ferring
Christof Langer
OSConsulting
Prof Dr Florian Priese
Anhalt University of Applied Sciences
Highlights
- How KPIs lead the Way to Continual Quality Improvement (CQI)
- Correlation with Process Controls, Quality Costs and Business Continuity
- Psychological Aspects and Case Studies
Zielgruppe
Managers and Executives from pharmaceutical Quality Assurance and Quality Management but also Business Executives and Production Managers and those involved managing the continuity of product supply.
Zielsetzung
In this two-day Master Class, leading experts will explore expectations and requirements for quality metrics and KPIs, as well as their links to Continual Quality Improvement (CQI), the cost of non-conformance and business continuity. You will gain practical insights to help turn your company’s quality excellence goals into reality.
Programm
Background
To remain regulatory compliant and ensure a reliable supply of products in a cost-effective way, companies must continuously evaluate their systems and processes, simplify them where appropriate and ensure that they remain under control. Accurate quality metrics, meaningful Key Performance Indicators (KPIs) and Continual Quality Improvement (CQI) are important tools in this context.
Quality Metrics and beyond
- Expectations of the agencies
- Quality Culture as the basis for quality improvements
- How to involve the management in Quality Metrics
- Set up of a practical review system
- Follow up actions on management reviews
Integration of Quality Metrics Systems and KPIs in Continuous Improvement and Business Continuity
- Understanding critical processes & where quality risks lie/ process mapping
- Defining the right KPIs
- Meaningful metrics (and the pitfalls)
- Quality Impact Assessment & effectiveness checks
- Opportunities for Improvement (OFIs), Continuous Quality Improvements (CQIs) and Business Continuity
Psychological Aspects of Continuous Improvement
- What do the numbers tell us?
- Business culture
- Empowerment of people
Assignment of Metrics and Correlation with Process Controls
- The importance of proper use and relevance of lagging and leading KPIs in correlation with process controls.
- The set up and implementation of a risk-based data evaluation methods for continual improvement and the Management Review
KPI Management: Turning Cost of Quality Data into Action – and the Role of AI
- Quality by the numbers: what are quality costs?
- How to determine the cost of poor quality
- Quantify – analyse - improve
- Calculating return on investment
- AI-supported KPI Management in the Pharmaceutical Industry
- Using AI to identify and reduce Quality Costs
Case Studies:
Quality Metrics as a Key Driver for CQI
- Why did we implement Metrics?
- How did we do it?
- What was the outcome?
- Lessons learned
- How to apply Quality Metrics as a Key Driver for CQI
KPIs Applied: The Turnaround of Deviations Handling
- Why did we need an intervention?
- Prognosing the future while understanding the past
- The flashlight effect; choose wisely
- Visual triggers for continuous improvement
- Tribal knowledge versus “real” data
Parallel Sessions:
1. Managing Data:
- The Bridge from Quality Metrics to CQI
- Defining the right KPIs and Meaningful metrics (work on examples)
- What to learn from the data
2. Quality Metrics Principles to foster Business Continuity
- Expectations of authorities, what is essential for performance metrics?
- The link to ICH Q12: Quality Metrics as part of Product Lifecycle Management.
- Case Study: Continual risk mitigation to transform lagging performance data into Leading Metrics and Quality Objectives
3. Constructing KPIs that drive high Quality Behaviour
- How to choose and use the correct tools and KPIs
You will be able to attend 2 of these sessions. Please choose the ones you like to attend when you register for the course.
Weitere Informationen
Venue
DoubleTree by Hilton Berlin Ku´Damm
Los-Angeles-Platz 1
10789 Berlin
Germany
Phone: +49 (0) 30/ 2127 714
E-Mail: info@doubletreeberlinkudamm.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.
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 lunch on both days, dinner on day one and all refreshments. VAT is reclaimable.
Get-Together
In the evening of the first day, you are cordially invited to a Get-Together. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
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.
Contact
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
DoubleTree by Hilton Berlin Ku´Damm
Los-Angeles-Platz 1
10789 Berlin
Germany
Phone: +49 (0) 30/ 2127 714
E-Mail: info@doubletreeberlinkudamm.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.
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 lunch on both days, dinner on day one and all refreshments. VAT is reclaimable.
Get-Together
In the evening of the first day, you are cordially invited to a Get-Together. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
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.
Contact
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
Participant Feedback from previous Courses
- “I am so grateful for having attended this course. Great job from all, and very profitable. Thanks!”, Alba Aranda Cuesta, Kern Pharma, Spain
- ”Just enjoyed all the presentations and as well the workshops” (A. Tigchelaar)
Datum & Uhrzeiten
Date
Tue, 25 May 2027, 09:00–17:45 h
(Registration and coffee 08:30–09:00 h)
Wed, 26 May 2027, 08:30–15:00 h
Tue, 25 May 2027, 09:00–17:45 h
(Registration and coffee 08:30–09:00 h)
Wed, 26 May 2027, 08:30–15:00 h
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
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This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"
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Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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