Lean GMP-Systems - Live Online Compliance – Efficiency – Quality

Lean GMP-Systems - Live Online

Course No 19518

This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager". Learn more.

All times mentioned are CEST.


Costs

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Anke von Harpe, QProgress
Arnoud Herremans, Lean Kaizen Consultant
Dr Andreas König, Quality König
Linda Reijinga, Ferring
Dr Frank Seibel, Roche Diagnostics
Francois Vandeweyer, VDWcGMP Consulting

Objectives

Learn how to design lean, efficient and compliant Quality and GMP-Systems that will support you in turning your quality goals into reality

Background

Those of us in the competitive and highly regulated pharmaceutical industry understand the need to balance operational efficiency with regulatory compliance. We must find ways to reduce complexities, eliminate redundancies and streamline operations while staying compliant with an array of regulations and guidance documents. Making changes to our quality processes requires overcoming challenges arising from these often competing interests.

However, to face regulatory requirements and expectations, pharmaceutical quality systems have been becoming more and more complex over the past years. In many companies, this has led to a certain inflexibility and inefficiency. But quality related processes, procedures and their related documents should monitor and support, not constrain the true core competence of pharmaceutical companies: the manufacture of cost effective medicines and APIs at highest quality and in compliance with the regulations.

Quality Managers need to know how to fulfil the regulatory requirements efficiently and how to implement the necessary processes in a lean and cost effective manner that supports efficacy and safety.

Target Group

Managers and Executives from pharmaceutical and API Quality Management and Assurance, Business Executives and Production Managers and those involved in continuous improvement projects.

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and e-mail address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

How Lean Thinking supports our GMP Status (Basic Lean SixSigma Tools)
  • Background and definitions:
    - Lean thinking
    - Customer value
    - Continuous improvement
    - Waste (in a process)
  • Fundamental problem-solving tools used to support Lean Six Sigma and other process improvement efforts
Lean and SixSigma Tools and how to apply them (Presentation and Workshop)
Learn and discuss how to implement and use the most important Lean SixSigma tools.
We will use a whiteboard tool during the workshop part of this session on day 2. To foster interaction between the delegates, WebEx Meeting as training platform (instead of WebEx Events) will be used for this session. Delegates will receive two links for the overall live online training.

Case Studies:

Linking Lean and Quality
Discussion of various case studies in two dedicated sessions, for example:
  • Use historic data
  • Get out of a mess
  • Make use of a network
Lean (Documentation) Systems
  • Background
  • Tools and structural elements for efficient GMP documents
  • Training – how to ensure the right level for each role
  • Case study: Batch Record Review to the point
APIs: How to use Risk Assessment and Criticality Analyses to improve Quality Processes
  • How to develop syntheses and process criticality analyses and use the benefit in:
  • Lean deviation handling
  • Lean batch record review
  • Lean release process
Efficient Data Pooling: KPIs, PQR, APR, Management Review
  • How to define meaningful KPIs?
  • What are useful KPIs?
  • What risks are involved using KPIs?
  • How to drive the development of an underperforming
  • Quality System
Kaizen as a Powerful Tool for Optimisation of complex Processes
  • Does the system fit to the company?
  • Methods for determining needs and finding solutions
  • Customer-oriented project planning as a central success factor
Using LEAN Thinking for Improvements in the Quality Management System (QMS)
  • Experiences in using LEAN/Six sigma methodology for QMS improvements
  • Examples of process simplifications (e.g. Change Control)
Optimisation of the Ferring Supply Process and EU Hub Release
  • Process analysis
  • Improvement actions
  • Evaluating and Monitoring Effectiveness

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