Application of Design of Experiments to Process Characterization

Conducted by Steven Walfish
President, Statistical Outsourcing Services

June 20, 2008

Would you like a better understanding of how design of experiments is applied to process characterization?

This web seminar provides the techniques and approach to ensure that critical variables are identified and investigated for their impact on the process.

The presentation provides information on a representative strategy to utilize design of experiments for process characterization across an entire company and for new processes within the company.

Steven L. Walfish, a well-known consultant in statistical methods for biotech, pharmaceutical and medical device companies will conduct this seminar. He is a member of the Editorial Advisory Committee for Biopharm magazine, and has presented at numerous conferences on validation.

Specific areas that will be covered include:

  • Regulatory Requirements for Process Characterization Study (PCS)
  • Design for Six Sigma perspective on PCS
  • Design of Experiments tools common in PCS
  • Systematic application of DOE

Lasting just one hour, you will be able to follow along on this web seminar with a PowerPoint presentation constructed specifically for this seminar. You will be able to submit oral or email questions to Mr. Walfish during and after the formal presentation.

By the end of the hour, you should have a better understanding of the ICH Q8 Design Space and common statistical methods used in Process Characterization.. A detailed outline follows and Mr. Walfish's qualifications are below.

Application of Design of Experiments to Process Characterization

Part I - Overview of Process Characterization Study

  • Why Process Characterization is important
  • Design for Six Sigma
  • Benefits of the using Process Characterization

Part II - Best Strategies for PCS

  • Screening Experiments
  • Optimization Experiments
  • Transmission of Variation
  • Tolerance Analysis
  • Testing to Failure

Part III - Planning a PCS

  • Selection of variables
  • Selection of the best experimental design

Part IV - Case Study

Part V - Questions and Answers

  • Steven Walfish will field your questions live on the phone. You will hear all questions and answers from all participants of this seminar.

Register now!

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All registrations include handout materials. Once you’re registered, you will receive via e-mail (the e-mail address you provide in your registration) the web location to download the handout materials.

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Get the CD and handout
GMP080620E - CD and Handout materials
Application of Design of Experiments to Process Characterization
CD price includes all HANDOUT MATERIALS and audio CD. CD will be shipped three weeks after the seminar		 $397.00 Add to Cart

Instructor

Steven Walfish - MS, MBA, President, Statistical Outsourcing Services
Mr. Steven Walfish brings two decades of industrial experience providing statistical solutions to complex business problems. Mr. Walfish was Senior Manager Biostatistics, Nonclinical at Human Genome Sciences in Rockville MD. Human Genome Sciences (HGS) is a biopharmaceutical company specializing in the discovery and development of protein and antibody therapies for unmet medical needs. Mr. Walfish provides statistical methods for data collection, analysis and reporting. Mr. Walfish has held positions with PricewaterhouseCoopers, Chiron Diagnostics and Johnson & Johnson. Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.

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