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Design of Experiments for Process Validation - Public Seminars

solutionLeading medical device companies have discovered the power of using experimental design techniques during their Process Validation activities. Instead of just assuming they know the key input variables for a process, they use design of experiments (DOE) to generate a mathematical model of their process. This model can then be used to determine optimal set points for multiple responses or outputs. DOE can also demonstrate what variability can be tolerated in the input settings while continuing to produce product that meets predetermined specifications.

Launsby Consulting has been teaching design of experiments techniques to medical device companies for over 20 years. As early as 1990, we were the leading advocates of design of experiments for process validation. In 2004, the GHTF guideline on process validation was released to industry. It highlights the use of design of experiments and Taguchi Methods as a leading mathematical tool for validation initiatives.

Attend this two day seminar and learn how to successfully apply simple and intermediate design of experiments techniques to your process validation activities.

Cost: $1500.00

Call 1-719-282-1143 to Register.

Click on the tabs below for more information.

Objectives

Attendees will:

  • Learn how DOE can be used to enhance your Process Validation activities.
  • Learn the benefits of orthogonal array experiments over best technical guess or one-factor experiments.
  • Learn how to quickly determine key input variable set points.
  • Learn how to use DOE to determine process windows.
  • Learn how to quickly and effectively analyze experimental results using software.
  • Learn how to determine best trade-offs for multiple output variables.

Agenda

  • Goals, outcomes, expectations
  • The challenges facing medical device organizations
  • What are the Process Validation requirements?
  • How DOE links with IQ, OQ, and PQ
  • What is a multi-factor experiment?
  • What are the benefits?
  • Powerful medical device case studies of DOE in action
  • What are the steps in Process Validation and how DOE fits with each step?
  • DOE checklist
  • Simple orthogonal arrays, full factorials, Taguchi designs, and fractional factorial designs
  • Graphical analysis
  • Analysis using ANOVA and MLR (focus on computer output)
  • Verfication of experimental results
  • Analysis of variance reduction
  • Analysis of multiple simultaneous responses
  • Group exercises

 

Trainer

Robert Launsby has taught thousands of students Design of Experiments techniques and hundreds in the area of Six Sigma. Bob has consulted with numerous companies in the area of FDA protocols for Process Validation. He is co-author of "Process Validation for Business Success", "Design for Six Sigma", "Engineering Today's Designed Experiments", "Understanding Industrial Designed Experiments" and "Experimental Design for Injection Molding". Bob's presentations are lively and informative. His examples are practical and thought provoking.

Dates/Locations

The dates and locations are listed below:

Location Date
Colorado Springs, CO June 12 & 13, 2017
Colorado Springs, CO October 19 & 20, 2017

Cost

Fees: $1500 includes the book Engineering Today's Designed Experiments, Participant Guide and a 45 day trial version of DOE Wisdom software. Participants may purchase DOE Wisdom for an additional rate of $695.00. (Normally $895.00) Lunch and coffee breaks are provided each day.

Guarantee

Launsby Consulting seminars and products are fully guaranteed. If any of our seminars do not meet your needs, contact us and we will promptly send you a refund. If any of our products fail to meet the highest standards of quality and performance, please return them in like-new condition in their original packing materials, and we will send you a refund.

 

Refund Policy

When cancellations are made at least 14 days prior to the seminar date, we will refund your registration fee minus a $100 processing fee

 

Register Early - class sizes are limited for optimal interaction and instruction.

Call 1-719-282-1143 to Register.

If you have any questions, please feel free to email us at or call us at 1-719-282-1143.

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