PharmStat

Statistics for Pharmaceutical Manufacture and Compliance in FDA regulated industry.

Carrying on a 30+ year tradition of cCGMP statistics and their pragmatic application, we are dedicated to:

  • Leading the application of Mathematics to solve problems of Industry and Government.
  • Guiding clients through regulatory impacted statistical challenges and system design appropriate to their business needs.
  • Teaching our passion for statistics and engineering.

Our purpose is the practical application of engineering statistics in FDA regulated Manufacture and Compliance.
Our corporate vision is to lead people in building coherent frameworks from data to structure and guide good risk based decision making.

A Chemical Engineer and Applied Statistician, Jason J. Orloff has over ten years experience working directly in Manufacturing, Qualification & Validation, Quality, R&D, and Business Development. In that time he has saved millions of dollars for multinational corporations and built business appropriate cGxP systems for start-ups. Please contact us for a free initial consultation on any statistical, manufacturing, or compliance issue.

Upcoming Events

April/May 2012 - “QbD: Sufficient Statistical Confidence”, Chicagoland Pharmaceutical Discussion Group (CPDG), an AAPS affiliated section, for a dinner meeting (approximately 5:30-8:30 pm).

February 14-15, 2012 - “Mixture Designs For Optimal Formulations (Mix)”, An Introduction to Mixture Designs, Stat-Ease, Minneapolis, MN, http://www.statease.com/clas_mix.html

August 6-10, 2012 - “QbD: Is It about Specification or Sampling Plans?”, 52nd Annual Pharmaceutical Analysis Conference, Devil’s Head Lodge, Merrimac, WI

TBD - “Validation by Design”, An Introduction to Factorial Design of Experiment for Processes, PDA TRI, Washington DC.

TBD - “Pharmaceutical Statistics: Process Validation and Ongoing Monitoring”

 

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