Petra Barth, QS-Training.de, Germany
Cecilie Hejlskov, Xellia Pharmaceuticals, Denmark
Arnoud Herremans, Lean Kaizen Consultant, Netherlands
Henny Koch, Qimp B.V., Netherlands
Dorthe Christina Kroun, Ascendis Pharma, Denmark
Jason McGuire, Fagron, USA
This 2-day Master Class brings together well-experienced experts to discuss the latest expectations and requirements for Quality Metrics and KPIs and how they are linked to Continual Quality Improvement (CQI), the cost of non-conformance and Business Continuity. This will support you turning your company’s quality excellence goals into reality.
To remain ‘regulatory compliant’ and to ensure the continuity of product supply in a cost-effective way, systems and processes must be evaluated and the respective processes simplified and controlled. Important tools in this context are accurate Quality Metrics, the right Key Performance Indicators (KPIs) and Continual Quality Improvement.
Quality Metrics in itself are not new, though. They have already been used in pharmaceutical industry for years –mainly internally to measure operational performance. But quality can be measured on different levels and for many processes. Done in the right way, Quality Metrics can enable companies to reach a high-quality performance. They will benefit from a continuous improvement in both operational performance and GMP compliance. And both are important for the continuity of business and product supply.
A good quality metrics system supports both industry’s profitability and GMP compliance. But a good system precludes overproduction of metrics; you only measure what adds value to quality in the most efficient way. This way the metric system is fit for purpose, enables you to maintain a high-quality standard and allows you to lower your costs for quality. This can drive the price down and renders continuity to the business at the same time. To make this happen, industry must come together in courses like this to learn and discuss how to build a better quality system using smart quality metrics.
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.
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)
- The role of Quality Impact Assessment & effectiveness checks
- The link to 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
KPIs and the Cost of Non-Conformance
- Quality by the numbers: what are quality costs?
- How to determine the cost of poor Quality
- Quantify – analyse - improve
- Calculating return on investment
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
FDA’s Quality Metrics Program
- What is the status of the FDA Quality Metrics Program?
- The new Quality Metrics Feedback Program and Quality Metrics Site Visit Program
- Experience made with the FDA Quality Metrics Pilot Phase
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 (2 out of 3)
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.