Introduction to Lean Six Sigma for Biomanufacturing: Making Operational Excellence Work

Why should you attend?

  • Gain Operational Excellence (OPEX)
  • Learn dispersion analysis and process capability skills
  • Acquire a balance between hard, technical Lean Six Sigma (LSS) and soft project leadership skills in three days
  • Learn about critical quality parameters (CTQs), fishbone diagrams, and how to reduce variation for the Quality by Design ‘desired future state’  

This course introduces the fundamental tools and methods used to implement a Lean Six Sigma program.  Lean Six Sigma principles such as reducing waste and variation have been adopted by a range of organizations to guide continuous improvement and are used in the large pharma companies like Pfizer and Genentech with good OPEX success.  This course introduces the basic Lean Six Sigma tools and methods with a focus on application to the pharma/biopharma industry. As your organization seeks to overcome internal inertia and separate the winners from the losers, and as you begin to think of change, focus on a sustainable strategy like Lean Six Sigma with a direct impact on people within your organization (Friedli et al).

Attend and you will learn

  • How lean six sigma (LSS) got its start in the pharmaceutical/biopharmaceutical industries
  • To apply the techniques taught in a solution prep lab, an on-site, hands-on lab at BTEC facility to reinforce the training with data collection and data analysis
  • How to use the DMAIC (Define, Measure, Analyze, Improve, Control) platform
  • Lean Six Sigma Tools, technology and methods, and project team management, including but not limited to the following topics:
    • Pareto analysis
    • Dispersion analysis
    • Basic process
    • Process mapping
    • Cause-and-effect analysis (fishbone diagram)
    • Graphical tools
    • Process capability—process variation
    • ‘Voice of the Process’
    • Material variation
    • DPMO
    • Classifying data:  Attributes and continuous variables
    • Reducing variation
    • Capability and control
    • SPC with chart examples
    • Types of variation
    • Common and special causes
    • Basic control chart and components
    • “Where does the data lie?”

Pharma companies are pushing ahead to evolve in quality by using a Quality by Design (QbD) approach. This course may help define product quality attributes needed for QbD. CTQ criteria, material attributes, process parameters and sources of variability will be discussed. The fishbone diagram will be utilized and practiced, which may be useful to a company in pursuit of QbD. 

Who should attend

  • Quality professionals interested in LSS;
  • Project teams should attend for a refresher on basic protocol
  • QbD project groups
  • Teams just getting started on a new project can attend for one-on-one personal coaching from the instructors.
  • Green belts, champions, and team members requiring knowledge of the basic tools
This technical training course is targeted for the biopharma audience interested in learning the foundation of lean six sigma and how it can help improve your project outcomes. The tools covered will enhance your projects, whether you are established green belt, black belt or master black belt or if you are just getting started in your organization. 

Attend and you will receive

  • 2.2 CEUs
  • Morning coffee
  • Lunch
  • Afternoon beverage break
  • The Lean Enterprise Memory Jogger book
  • Certificate of attendance


Roy H. Johnson, Ph.D., and Margaret G. O’Brien will lead this course. Together, they have decades of experience in Lean Six Sigma, engineering and management and have had hundreds of Six Sigma projects certified.

FEE and Discounts available


  • A 20% discount is available to:
    • Employees of BMF companies
    • Groups of five or more from one company registering for the same offering of this course
    • Individuals registering for more than one course at a time
  • A 50% discount is available to faculty/staff working in academic environments

  • A special discount is available to members of the Society for Industrial Microbiology and Biotechnology (SIMB)

Please see detailed information about discounts on the online registration site.


Cancellation by registrant

To cancel a registration and be eligible for a refund of course fees, you must notify BTEC by e-mail to or fax to 919-513-1697. Fees are refunded according to the following schedule:

    • 100% refund – If notification is received at least 10 business days in advance of course start date
    • 75% refund – If notification is received 6-9 business days in advance of course start date
    • No refund will be issued if notice is received 5 or fewer business days in advance of course start

Substitutions may be made up to two business days prior to the course start date; notify the BTEC office by fax at 919-513-1697 or by e-mail to

Cancellation by BTEC

BTEC retains the right to cancel a professional development short course no less than 10 business days in advance of the scheduled course start date. Registrants will be notified by BTEC if a course is cancelled and will receive a full refund of registration fees paid. BTEC is not responsible for airfare penalties or other costs incurred due to cancellation.