Sprecher
Dr Siegfried Hackl, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
Arnoud Herremans, Lean Kaizen Consultant
Michael Hopper, GxPpro
Dorthe Christina Kroun, Bavarian Nordic A/S, Denmark
Aidan Madden, FivePharma
Zielsetzung
This Course will show you examples and possibilities which will help you improving your quality performance. You will learn how to use the various tools to drive Continuous Quality Improvement.
Hintergrund
The quality of pharmaceutical products is determined by the effectiveness of the Quality System and the people operating it. Unfortunately, many Quality Systems have become complex, slow and bureaucratic.
To remain ‘regulatory compliant’ and to reduce costs, systems and processes must be evaluated and the respective processes simplified and controlled. Important tools in this context are accurate GMP performance measures and analysis, the right Key Performance Indicators (KPIs) and tools like the Balanced Scorecard.
Although ICH Q10 is still reproduced in Part III of the EU-GMP Guide, several principles of ICH Q10 have been incorporated into the new Chapter 1of Part I, including continuous and continual improvement.
This course will provide you with practical guidance on:
How to select the right KPIs and Quality Metrics for your Quality System
How to make your Quality System more efficient
How to improve your processes
How to reduce costs
Zielgruppe
QA personnel who wants to improve their quality systems and increase performance and regulatory compliance but also managers and supervisors who are responsible for cost effective and ‘low risk’ quality operations.
Programm
A: Continuous Quality Improvement
The basics of Continuous Quality Improvement
History
Applicability
Outlook
Techniques to evaluate Quality Performance
Process Analysis
Root Cause Analysis
Cause-and-Effect Diagrams
Risk Assessment
Quality Cockpit
KPIs, Tracking & Trending
Implementation of Continuous Quality Improvement
Pre-requisites inside a company
Accountability and ownership
Planning of resources
Business culture
Empowerment of people
B: Transform Strategy into Action
Implementation and efficient Use of a Balanced
Scorecard
Balanced Scorecard as a strategic performance management tool
Design
Implementation
Change Management as the Key
How shift individuals, teams, and organisations from a current state to a desired future state
How to organise processes to empower employees to accept and embrace changes in their current business environment
8 Steps of Change (Kotter)
C: Workshops
KPIs and GMP Performance Measures
Analysis tools for Assessing and Optimising Process Flows
Case Studies:
How to translate Data and Knowledge into Action
Case study 1: Cycle Time of Documents
Case study 2: Deviation Reporting and CAPA Systems
Case Study 3: Quality Metrics as a Key Driver for CQI
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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