Lean GMP Systems

Lean GMP Systems

Barcelona, Spain

Course No 17265


Costs

Non ECA Member: EUR 1690,--
ECA-Member: EUR 1490,--
EU/GMP Inspectorates: EUR 845,--
APIC Member Discount: EUR 1590,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

María J. Prol García, Novo Nordisk, Denmark
Anke von Harpe, QProgress
Arnoud Herremans, Lean Kaizen Consultant
Dr Andreas König, Fidelio Healthcare
Linda Reijinga, Ferring
Francois Vandeweyer, VDWcGMP Consulting
Michael Schousboe,  Novo Nordisk, Denmark

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.

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

 Parallel sessions (2 out of 3):
1. 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
 2. Lean and SixSigma Tools and how to apply them
  • Learn and discuss how to implement and use the most important Lean SixSigma tools.
3. 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 nderperforming Quality System
You will be able to attend 2 of these sessions.Please choose the ones you like to attend when you register for the course.

Case Studies:

Linking Lean and Quality
Discussion of various case studies in two interactive 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
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
  •  Deep dive in creating a LEAN CAPA process
Optimisation of the Ferring Supply Process and EU Hub Release
  • Process analysis
  • Improvement actions
  • Evaluating and Monitoring Effectiveness

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