Instructor
Jason J. Orloff, Chemical Engineer & Statistician, PharmStat
Jason J. Orloff, a chemical engineering applied statistician, is principal statistical consultant at PharmStat. An international consultant, he specializes in applied statistics and experimental design for development, quality assurance, quality control, validation, and production under the cGXP’s. Current activities include an author of ISPE’s Baseline Guide for Q10 chapter “Process Performance and Product Quality Monitoring”, contributing authorship of the PDA’s Technical Report 59 on “Utilization of Statistical Methods for Production and Business Processes”, and publications in the Journal of Pharmaceutical Technology. Jason brings twenty years of experience in pharmaceutical manufacturing, quality, and regulatory affairs. Areas of expertise include PAT, OOS, SQC, SPC, assay validation and setting specification criteria. A Chemical Engineer with real-life expertise at applying statistics in a highly regulated environment, Jason is able to work effectively across all levels of an organization as well as make high level concepts accessible to a variety of audiences. Jason has worked with a wide variety of companies including pharmaceuticals, parenterals, biotechnology, fine chemicals, medical devices, food, and nanotechnology. He holds a BS in Chemical Engineering from UWMadison and an MS degree in Applied Statistics from DePaul University.
Thursday, 28 September 2017
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9:00
Welcome
Instructor Lead discussion on DoE fundamentals from management's role to ensure that funds are spent most efficiently for the good of the corporation to the researcher's responsibility to deliver actionable outcomes within budget and on time.
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10:30
Coffee Break |
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11:00
Examples of the prioritization of resources through risk assessment will be introduced using Japan's National Institute of Health Sciences, Sakura, and the PDA's iVAX case studies.
The incremental change to traditional scientific methods will be explored in the Pharmaceutical context.
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12:30
Lunch Break |
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13:30
Both a classical and a fractional factorial study will be designed by hand using "an intern's plastic syringe extrusion project" as a start point.
Basic concepts using only addition, subtraction, and division
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15:30
Coffee Break
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16:00
Both a classical and a fractional factorial study will be designed by hand using "an intern's plastic syringe extrusion project" as a start point.
Basic concepts continued – no computers necessary.
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18:00
End of Day 1
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Friday, 29 September 2017
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9:00
The way you present the data influences how we think about the data: Analysis using Graphical Tools
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10:30
Coffee Break |
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11:00
Numerical Analysis: "If you doubt it, count it." ~ Francis Galton
Understanding & Presenting Results
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12:30
Lunch Break
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13:30
Pharmaceutical Case Studies from 30 years of Scientific Literature
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15:00
Coffee Break |
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15:30
Case Studies continued (Placket Berman Designs for validation as time permits)
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16:30
End of Training Course |