Lean GMP Systems - Compliance – Efficiency – Quality

28-29 October 2015

Berlin, Germany

Course No 9232

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Speakers

Dr Afshin Hosseiny, Tabriz Consulting
Dr Andreas König, Aenova Group
Owen Prichard, Midatech Biogune, Spain
Linda Reijinga, Ferring
Dr Bernd Renger, ECA

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

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 lead to a certain inflexibility and inefficiency. But properly implemented, Quality and GMP-Systems will support the manufacture of medicinal products efficiently and without creating a big burden on the company’s resources. Quality related processes, procedures and their related documents should control 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 regulation.

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 rather than hinders it with unmanageable systems.

Target Group

Managers and Executives from pharmaceutical Quality Management and Assurance, Business Executives and Production Managers and those involved in continuous improvement projects. But also Quality and Business executives from smaller organisations with highly constrained resources

Programme

How to gain Efficiency in the Quality Unit without compromising Quality
Systems to reduce deviations
How do you measure quality?
How to develop a control strategy
How to facilitate quality based decisions using risk management techniques

Managing Compliance and the Cost of Compliance in a globalising World
Intercultural compliance
Supplier quality vs. quality excellence
Cultural particularities in GMP understanding
Import: CoA, CEP, GMP-certificate, audit – what to look for
The Cost of Compliance

The modern QA Organisation
Developing a QMS to support business objectives while remaining compliant
Developing QA organisation to support seamless operations: How can QA manage
process validation
change management
batch disposition
inspection readiness
without reducing efficiency and increasing costs

In Time Management of Quality
Working to avoid instead of repairing
How to use PAT
Risk Management
Quick workflows

How to reduce the Number of SOPs while remaining in Compliance
Rationalise the existing SOPs
Reduce the total number
Introduce an efficient SOP review process
Remain compliant with the cGMP requirements

Efficient Training Documentation
Determine initial situation and define the objective
Clarify the process, content and responsibilities
(commitment of management)
Decide on an adequate software
Adjustment / optimisation / Lean aspects / KPIs
Verify substantial quality of training

Case Studies:

Linking Lean and Quality
Discussion of various case studies in an interactive session.

How to reduce the Number of SOPs while remaining in Compliance
Rationalise the existing SOPs
Reduce the total number
Introduce an efficient SOP review process
Remain compliant with the cGMP requirements

How to use Lean SixSigma Tools in Practice
Example: Optimisation of the Ferring EU hub release processes
Process analysis
Improvement actions
Evaluating and Monitoring Effectiveness

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