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5 day Lean Six Sigma Green Belt for pharmaceutical and biotech excellence. Certification by CSSC or IASSC and 3 hour coaching


Lean Six Sigma (LSS) is a proven methodology for business process improvement which nearly all Fortune 500 companies have implemented within their organizations, saving billions of dollars and boosting their revenues.


As the pharmaceutical and medical device companies are under constant pressure to reduce cost, while still maintaining the quality (and safety!) of their products and services, continuous improvement and operational excellence programs are key to create a sustainable competitive advantage.


This green belt level course has been designed specifically for professionals working in the pharmaceutical and biotech industry who wish to learn more about this proven approach which could transform their organizations.


You will leave the training room with a crystal-clear understanding of the main tools of the Lean Six Sigma Green Belt Body of Knowledge. Certification is available with either The Council for Six Sigma Certification (CSSC) or the International Association for Six Sigma Certification (IASSC). The CSSC exam is non-timed,open-book and consists of 100 multiple-choice and true/false questions from the major sections of CSSC Six Sigma Green Belt “Body of Knowledge”. Course Participants will have 3 attempts to successfully pass the exam with the required minimum score. CSSC certifications have no expiration date and do not require re-certification. The IASSC certification exam is a 3 hour closed book 100 question proctored exam.


The course will provide participants with a clear understanding of the concepts, implementation and objectives of Lean Six Sigma. By the end of the course, participants will have developed the ability to:

  • Navigate the challenges of Lean Six Sigma in Pharma

  • Implement a structured approach to process improvement

  • Identify root causes as well as predict, prevent and control defects

  • Implement sustainable quality improvement using the DMAIC methodology

  • Analyse data and develop qualitative and quantitative performance indicators

  • Identify Waste within their internal processes

  • Apply concepts learned to pharmaceutical case studies

  • Design Kaizen events

  • Lead a simple Lean Six Sigma project

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IASSC Green Belt and Black Belt Zurich and Basel Switzerland

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Dr. Fabio D'Agostino 
Lean Six Sigma Accredited Trainer. 


  • Engineering Doctorate in Biopharmaceutical Process Development : Newcastle University, UK

  • Lean Six Sigma Black Belt

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There are no course prerequisities for this 5-day Lean Six Sigma Green Belt for Pharmaceuticals and Biotech other than a basic understanding of mathematics and experience in the Pharma / Biotech industry. Those students already holding a Lean Six Sigma Yellow Belt certification may benefit from their prior knowledge and understanding of overlapping concepts across both courses. 

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  • Lean Six Sigma Fundamentals

  • Lean Six Sigma in the pharmaceutical industry

  • Nine wastes of the pharmaceutical industry

  • Class game- “spot the waste”

  • 5 S

  • Takt time, FTY and RTY

  • Guided exercises on Takt time, FTY and RTY

  • Introduction to DMAIC




  • Define phase

Problem and project selection

Business Case

Project Chapter

DIY (‘Do it yourself’) Class exercise

Discussion on DIY group exercise and lessons learnt

Value stream map and SIPOC

  • Case study 1 – FDmAb

  • Measure phase

Understanding and plotting data

Measurement System Analysis

Prepare a data collection plan

Reviewing basic descriptive statistics: sampling, central tendency, spread

Process discovery tools (Pareto, FMEA, Fishbone)

Measuring the baseline (current state) and common capability indicators

Exercises in Excel and Minitab




  • Analyse phase

Multi-vari Charts (example and guided Minitab exercise)

Correlation and regression Analysis (minitab exercise)

Hypothesis testing (examples)

Introduction to Design of Experiment

Case study- BostonPharma




  • Improve phase

Mistake proofing and poka yoke

Game – Design your poka yoke

Lean tools implementation

Kaizen events and continuous improvement

Case study (guided)- NY FDBio

Discussion and lessons learned

Quiz (exam preparation)





  •  Control phase

Control plans

Statistical process control (SPC)

Control charts for sustainable change management

  • DMAIC exercise (DIY)

  • Group discussion and lessons learnt

  • Course summary and exam preparation

  • CSSC Green Belt Certification EXAM 


For more info please contact Dr Fabio D’Agostino



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