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Event Details

Lean Sigma for Bio Companies Symposium

  • February 02, 2011
  • 7:30 AM - 1:30 PM
  • Loyola College, Columbia MD
  • 36


  • General public, MWCC members
  • Invited speaker or special guest

Registration is closed

Lean and Six Sigma are not just for large firms!  They have significant, proven benefits for small and start-up bio companies.  Come find out how to:

  • Improve the efficiency of your research effort
  • Make your working capital go further
  • Decrease your time to market
  • Reduce potential delays with your FDA submission

Come to the Lean Sigma for Bio Companies Symposium and learn how to improve your operations. Sponsored by the Maryland World Class Consortia and the Maryland Biotechnology Center, this symposium will help you understand and apply Lean Sigma in small and start-up bioscience companies. 

When biotech companies implement Lean and Six Sigma, they develop powerful tools that improve quality, compliance, productivity, costs, and speed.  Ultimately, this lets them to bring better products to market faster and more cost effectively.

These are not just issues for large bioscience firms.  In fact, they are probably more critical for young, early-stage bioscience companies.   Without understanding critical process parameters, the language and research data submitted in FDA filing could severely impede any improvements or changes you may want or need to make in the future. 

In addition, raising capital for bioscience companies is always hard.  Venture Capitalists (VCs) and other funding providers understand that streamlined operations make the best use of precious capital resources. 

Presentations will be given by individuals who have experience implementing these practices in small bioscience companies.  Experienced practitioners and topic experts will include small bioscience company lean practitioners, FDA, VC community, and consultants who will discuss:

  • The Lean and Six Sigma tools
  • Tips on preparing for regulatory inspection before FDA filing
  • Process Analytical Technology (PAT) for establishing critical parameters in your process
  • Design of Experiments (DOE) in research and development
  • Risk Analysis and Failure Modes Effects Analysis (FMEA)

The Symposium includes continental breakfast and a one-hour expert panel discussion.  Registration also includes Lunch with the Experts, where you can discuss a topic of special interest to you and your company with an expert of your choice.

Join us on Wednesday, February 2, 2011 from 7:30 am to 1:30 pm for the Lean Sigma for Bio Companies Symposium and learn how small and start-up bio companies can use Lean Sigma to improve the operation and performance.  Speakers have experience implementing these techniques in small and start-up bioscience companies.


  • 7:30 am   - Registration and breakfast
  • 8:00 am   - Introductory remarks
  • 8:15 am   - Lessons learned - mistakes that could have been avoided, if only we had known about lean
  • 8:45 am   - Introduction to Lean Sigma
  • 9:15 am   - Tips to prepare for pre-approval/pre-license inspections
  • 9:45 am   - Break
  • 10:00 am - Process Analytical Technology
  • 10:30 am - Design of Experiments in R&D
  • 11:00 am - Risk Analysis and FMEA
  • 11:30 am - Panel Discussion
  • 12:30 pm - Lunch with the Experts
  • 1:30 pm   - Adjourn

Lunch With The Experts: Have lunch with the expert of your choice to discuss one-on-one topics most important to you and your company.  Paid attendees will be given first priority on a first-come, first-served basis.  Topics include:

  1. Lean in a research tools companies: Jingping Yang, SA Biosciences
  2. ROI of lean in bioscience: Jeff Fuchs, MWCC
  3. Preparing for regulatory pre-approval/pre-license inspections: Anastasia G. Lolas, Biotech Manufacturing Team, DMPQ, Office of Compliance, CDER, US FDA
  4. Risk analysis for critical processes: Steve Welsh, OPxcel
  5. PAT and regulatory inspections: John Davis, Baxter Healthcare
  6. DOE in R&D to save time/money: Renee Howell, Canon US Life Science, Inc.
  7. Lean Sigma and the regulatory process: Lauri Shropshire, MWCC
  8. Efficient use of capital: Michael Gutch, HIG BioVentures
  9. Lean for small bioscience companies: Jim Hardy, Hemacell Perfusion
  10. Lean for all size companies: JeanMarie Markham, Clinlogix

Additional support is provided by:

  • The Division of Natural Sciences, Loyola University Maryland
  • The Greater Baltimore Technology Council

Fee:  $50.00

Location: The Loyola University Maryland, Graduate Center, Columbia Campus is located at 8890 McGaw Road, Columbia, MD 21045.  Directions are available Loyola's website.

QuestionsContact Chuck Montague at cmontague@choosemaryland.org or 410 767-3837

Download the Lean Sigma for Bio Companies Symposium flyer to share with your colleagues.

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