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 The Council for Six Sigma Certification (CSSC). The 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.
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:
- 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
There are no course prerequisities for this 5-day Lean Six Sigma for Pharm, Bio and Medical Devices course other than a basic understanding of mathematics ( GCSE level or equivalent). 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.
Training will comprise of a mixture of theory, practical examples, case studies and team exercise to consolidate learning. Teaching style is interactive and friendly where questions about LSS are encouraged. To maximize impact, course participants will also learn how to use Minitab and Excel for their LSS projects. Candidates will leave the training room at the end of the course with a crystal-clear understanding of the LSS tools which can be applied in a pharmaceutical company to help improve the quality of the service provided while reducing costs.
*Please note: events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.
- 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
- 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
- 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
Dr Fabio D'Agostino,
Lean Six Sigma Training Ltd.
Fabio started his career at the medical device company Sorin Group (now LivaNova) as Quality Assurance Engineer after a BSc and a MSc with honors in Biomedical Engineering from the Polytechnic University of Turin (Italy).
- Engineering Doctorate in Biopharmaceutical Process Development : Newcastle University.
- Parenteral Drug Association (PDA) Cell and Gene Task Force
- (members include executives from GSK, Novartis, Lonza, Johnson & Johnson, Tigenix, Bluebird Bio) with the aim to develop a manufacturing control strategy for cell and gene based medicinal products.
- Fabio is an IASSC Certified Black Belt
4 Christopher Street
London, EC2A 2BS