Dr Karl-Heinz Bauer
Training - Beratung - Coaching (form. Boehringer Ingelheim)
Referierende
Highlights:
- From Strategy to Key Figures (in Quality, Manufacturing and Packaging in Detail)
- Deriving Appropriate Metrics from a Corporate Strategy
- The FDA’s "Quality Metrics" and "Quality Management Maturity” Program
Zielgruppe
This Live Online Training is intended for employees and managers in the pharmaceutical industry, particularly those in the areas of
- Manufacturing, packaging, and plant engineering
- Quality control and quality assurance
- Pharmaceutical development
- Manufacturing of active ingredients and excipients
- Chemical and food industries
- Contract manufacturing, packaging, and analysis
This training is also intended for Qualified Persons (QP), heads of manufacturing or quality control, and individuals responsible for managing and supervising external service providers.
Zielsetzung
The role of a modern manager in the pharmaceutical industry or in contract manufacturing and testing requires not only compliance with GMP and FDA requirements but also the ability to handle a wide variety of business management tasks to successfully perform these duties. In addition to regularly collecting key performance indicators (KPIs) and tracking laboratory and operating costs, performance metrics, and cost allocation, annual planning processes and multi-year long-term planning are typically carried out. This requires knowledge that is not covered, or is only covered very superficially, in a natural science or technical education or degree program.
KPIs allow goals to be clearly defined and agreements to be made in a transparent manner. Conditions or changes in conditions can be precisely described and assessed using KPIs.
KPIs and Key Figures can generally be determined and measured with reasonable effort. However, care should be taken to select the right indicators and avoid measuring too many. Furthermore, the indicators should be balanced within the so-called “magic triangle” (quality, cost, time) and align with the company’s vision and strategy.
In this Live Online Training, you will gain the necessary overview and practical knowledge to successfully determine key figures in pharmaceutical manufacturing, packaging, quality control, and quality assurance. Following a clear presentation of the theoretical foundations, the individual key performance indicators will be introduced in detail. The knowledge gained will be reinforced through examples and applied in a practical exercise.
Programm
From Strategy to Key Figures – Why Numbers Provide Orientation
- The purpose and significance of Key Performance Indicators
- The potential and limitations of Key Performance Indicators
- Definitions, terms, and examples
- Vision, Mission, Strategy, Business Plan
- Balanced Scorecard
- Key Performance Indicator (KPI)
- Key Figures (KF) - Overview of metrics in the context of business operations:
- Cost Metrics (Business Metrics)
- Quality Metrics (Compliance Metrics)
- Time-Based Metrics (Value Stream Metrics)
Key Figures in Detail – What Counts in Practice?
- Definitions, purpose, and examples of the use of Key Figures in pharmaceutical manufacturing, packaging and Quality, for example
- Performance-Oriented Metrics
- Defect Rate & Defect Recurrence Rate
- Right-First-Time
- Complaint Rate
- Employee Training Level
- Rejected Batches / Destruction Rate
- On-Time Delivery & Production Service Level
- Planning Stability
- Utilization Rate
- Employee Flexibility Rate
- Value-Added Costs
- Yield
- Overhead Ratio / Management Margin
- Overall Equipment Effectiveness
- Average Lead Time
Practical Exercise & Example – Deriving and Applying Key Figures
- Determining Operational and Laboratory Key Figures using an example
- Linking Key Figures to a Corporate Strategy
- Compiling Key Figures into a Balanced Scorecard
Tips and Hints for Implementing Metrics Systems
The FDA’s "Quality Metrics" and "Quality Management Maturity" Program
- Explanation and scope of the programs
- Why Quality Metrics are so important to the FDA
- Current status of the programs
- FDA guidelines and regulations on Quality Metrics & Quality Maturity
- References & online sources
Q&A Sessions
- Two live discussion sessions will provide an opportunity to ask the speaker questions and engage in a group discussion
Weitere Informationen
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate plus VAT)
Non-ECA Members EUR 1,290
ECA Members EUR 1,090
APIC Members EUR 1,190
EU GMP Inspectorates EUR 645
The conference fee is payable in advance after receipt of invoice. VAT is reclaimable.
Non-ECA Members EUR 1,290
ECA Members EUR 1,090
APIC Members EUR 1,190
EU GMP Inspectorates EUR 645
The conference fee is payable in advance after receipt of invoice. VAT is reclaimable.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Dr Markus Funk, +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Mr Ronny Strohwald, +49 6221 84 44-51, strohwald@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 29 Sep 2027, 09:30–16:00 h
All times mentioned are CEST.
Teilnahmegebühr
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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E-Mail: info@concept-heidelberg.de
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