Arnoud Herremans, Lean Kaizen Consultant
Dr Afshin Hosseiny, Tabriz Consulting
Dr Andreas König, Fidelio Healthcare
Linda Reijinga, Ferring
Dr Bernd Renger, ECA
Francois Vandeweyer, Janssen Pharmaceutica
Learn how to design lean, efficient and compliant Quality and GMP Systems that will support you in turning your quality goals into reality.
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, guidance documents and regulations. 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 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 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.
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.
The Role of the Quality Organisation
Basic Lean SixSigma Tools
- How do you measure quality?
- How to facilitate quality based decisions using risk management techniques
- Developing a QA organisation to support seamless operations: How can QA manage process validation, change management, batch disposition, inspection readiness without reducing efficiency and increasing costs
Parallel sessions (2 out of 3):
1. How to implement new Regulations
- Fundamental problem-solving tools used to support Lean Six Sigma and other process improvement efforts
2. Lean and SixSigma Tools and how to apply them
- Is there a need to immediately implement any new regulation?
- How to implement them without disrupting day to day activities
- How to avoid failure to comply with the new requirements
- Are alternative approaches possible (can we always rely on a risk based approach)?
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 KPI?
- What are useful KPI?
- What risks are involved using KPI
- How to drive the development of an underperforming 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.
Linking Lean and Quality
Discussion of various case studies in two interactive sessions, for example:
How to reduce the Number of SOPs while remaining in Compliance
- Use historic data
- Get out of a mess
- Make use of a network
How to use Lean SixSigma Tools in Practice
- Rationalise the existing SOPs
- Reduce the total number
- Introduce an efficient SOP review process
- Remain compliant with the cGMP requirements
Process Criticality Analysis
- Example: Optimisation of the Ferring EU hub release processes
- Process analysis
- Improvement actions
- Evaluating and Monitoring Effectiveness
- How to develop syntheses and process criticality analyses and use the benefit in:
- Lean deviation handling
- Lean batch record review
- Lean release process