Zielgruppe
Quality personal and professionals from pharmaceutical manufacturing and quality control who want to get a comprehensive understanding of the CoQ and its implications for the pharmaceutical industry.
Zielsetzung
The primary goal of this live online training is to provide participants with a comprehensive understanding of Cost of Quality (CoQ) in the pharmaceutical industry and equip them with practical insights and strategies. The program will focus on key aspects such as understanding quality costs, determining the cost of poor quality, exploring CoQ in operations, and fostering a culture of quality improvement and innovation.
Background
What Is “Cost of Quality” (CoQ)?
CoQ in pharmaceutical manufacturing refers to the total cost incurred by a company to ensure that its products meet the required quality standards, including GMP-compliant production, quality control, quality assurance and quality improvement activities. This includes the cost of all activities taken up proactively to prevent defects and failures and to deliver good quality. So overall, CoQ is the cost incurred to deliver a quality product to the client (patient).
In the dynamic and highly regulated pharmaceutical industry, maintaining and improving product quality is paramount. A CoQ framework offers a structured approach to assess the financial impact of quality-related activities. By understanding and effectively managing CoQ, pharmaceutical companies can enhance operational efficiency, ensure compliance with regulatory requirements, and ultimately deliver safer and more effective products to the market.
To achieve this, it is important to understand CoQ and setting clarity in expectations is very crucial. The challenge is to achieve the right balance between quality and cost and achieve what is best for the patient and required by the regulations. All of this naturally leads to the question of how to measure CoQ and how to use this information to foster decisions.
CoQ in pharmaceutical manufacturing refers to the total cost incurred by a company to ensure that its products meet the required quality standards, including GMP-compliant production, quality control, quality assurance and quality improvement activities. This includes the cost of all activities taken up proactively to prevent defects and failures and to deliver good quality. So overall, CoQ is the cost incurred to deliver a quality product to the client (patient).
In the dynamic and highly regulated pharmaceutical industry, maintaining and improving product quality is paramount. A CoQ framework offers a structured approach to assess the financial impact of quality-related activities. By understanding and effectively managing CoQ, pharmaceutical companies can enhance operational efficiency, ensure compliance with regulatory requirements, and ultimately deliver safer and more effective products to the market.
To achieve this, it is important to understand CoQ and setting clarity in expectations is very crucial. The challenge is to achieve the right balance between quality and cost and achieve what is best for the patient and required by the regulations. All of this naturally leads to the question of how to measure CoQ and how to use this information to foster decisions.
Programm
Understanding Cost of Quality (what are Quality Costs and Costs of Non-Conformance?)
- Development of quality costs for drug production
- Generic manufacturers and production Costs
- Manufacturer discount and cost pressure
- Challenges and Trends - Cost driver quality Costs
- Explanation of CoQ methodology
- Cost of poor quality (CoPQ)
- Main categories within CoPQ
KPIs as a Tool for Measuring and Analysing CoQ
- Less is more: define reasonable KPI (for info or for action?)
- Generate understanding and buy in from team (department/site/global)
- Feedback loop: Measure - Analyse - Improve - Control
- “Saying No” and challenging status quo: discussions with team & management
CoQ in Operations: Benefits and Limitations
- How to ensure adherence to GMP and other quality requirements while minimizing CoQ
- The Link to Business Continuity
- Advantages of introducing CoQ
- Limitations of CoQ
- Quality Culture
Quality is all about Mindset!
- Understanding politics and stakeholders: influence of team Dynamics
- Change management when setting CoQ initiatives
- Why quality professionals should use a bike often?
Weitere Informationen
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.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
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.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Contacts
Questions regarding content:
Mr Wolfgang Schmitt, +49 (0)6221 84 44 39, w.schmitt@concept-heidelberg.de
Questions regarding Organisation:
Ms Sonja Nemec, +49 (0)6221 84 44 24, nemec@concept-heidelberg.de
Recording from 19 September 2024
Duration of the recording: 2 h 45 min
Duration of the recording: 2 h 45 min
Teilnahmegebühr
| ECA-Member*: | € 590,- |
| Regular Fee*: | € 690,- |
| EU/GMP Inspectorates*: | € 590,- |
| APIC Member Discount*: | € 640,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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