KPIs and Quality Metrics - Online Training Recording
Course No. 21796
Speakers
Arnoud Herremans
Lean Kaizen Consultant
Henny Koch
Qimp
Dorthe Christina Kroun
MinervaX
Jason McGuire
Fagron
Cecilie Hejlskov
Syntese
Christof Langer
OSConsulting
Objectives
This Live Online Training 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.
Background
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.
Target Group
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.
Technical Details
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.
Programme
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
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
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
Constructing KPIs that drive high Quality Behaviour
How to choose and use the correct tools and KPIs
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
Recording from 07/08 May 2024 Duration of the recording: approx. 10 hours
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more
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