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.
COURSE LEARNING OBJECTIVES
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:
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Navigate the challenges of Lean Six Sigma in Pharma
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Implement a structured approach to process improvement
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Identify root causes as well as predict, prevent and control defects
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Implement sustainable quality improvement using the DMAIC methodology
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Analyse data and develop qualitative and quantitative performance indicators
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Identify Waste within their internal processes
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Apply concepts learned to pharmaceutical case studies
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Design Kaizen events
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Lead a simple Lean Six Sigma project
Dr. Fabio D'Agostino
Lean Six Sigma Accredited Trainer.
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Engineering Doctorate in Biopharmaceutical Process Development : Newcastle University, UK
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Lean Six Sigma Black Belt
COURSE PREREQUISITES
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.
TEACHING OUTLINE
MONDAY
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Lean Six Sigma Fundamentals
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Lean Six Sigma in the pharmaceutical industry
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Nine wastes of the pharmaceutical industry
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Class game- “spot the waste”
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5 S
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Takt time, FTY and RTY
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Guided exercises on Takt time, FTY and RTY
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Introduction to DMAIC
TUESDAY
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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
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Case study 1 – FDmAb
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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
WEDNESDAY
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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
THURSDAY
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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)
FRIDAY
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Control phase
Control plans
Statistical process control (SPC)
Control charts for sustainable change management
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DMAIC exercise (DIY)
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Group discussion and lessons learnt
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Course summary and exam preparation
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CSSC Green Belt Certification EXAM
For more info please contact Dr Fabio D’Agostino fabio@lean6sigmatraining.co.uk