Benjamin Daum
Sandoz
Referent:innen
Prof Dr Ramzan Tabasum
Lonza
Prof Dr Florian Priese
Anhalt University of Applied Sciences
All times mentioned are CEST.
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.
Hintergrund
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.
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.
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 trainings 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.
Programm
Gesamtes Programm als PDF herunterladen
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?
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Seminarprogramm als PDF
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