Training

PharmStat offers both on-site training as well as many public courses through such trade organizations as PDA, ISPE, CRS, & other partners.

We emphasize the application of concepts so that your employees leave with more than just exposure to a topic. Our students develop new skills and can apply them. Click on the titles below to see course descriptions or contact us for a brochure.

Available Courses and Seminars:

  • Intro to Design of Experiments with Applications to Design Space, Tech Transfer, and Validation (aka Validation by Design®) »

    2 days
    Non-mathematical introduction to designed experiments for Quality by Design, product and process design, formulation development, ICH Q8, and validation using full and fractional factorials and Plackett-Burman designs. Intended for all staff levels.

  • Pharmaceutical Statistics: Process Validation and Ongoing Verification »

    2 days
    This pragmatic two day course introduces the fundamentals of pharmaceutical statistics. It is meant for those who want their first course in statistics or for those who wish to have an introductory refresher of basic concepts. Attendees will begin immediate use of statistical techniques in compliance with the 2011 PV Guidance and ICH documents.

  • Statistical Tools Supporting Quality Risk Management and Analysis (ICH Q9) »

    1 day
    Quality risk management and analysis are supported and facilitated by the use of appropriate statistical tools and techniques. Effective data assessment is enabled by statistical thinking and graphical presentations. This course presents some of the principle statistical concepts and tools commonly used in the pharmaceutical industry. These tools also support HACCP and FMEA. The class includes hands-on case studies, quizzes and exercises.

  • Design of Experiments: Lyophilization »

    2 days
    A basic introduction to the Design of Experiments using Lyophilization as a case study. This Introductory DoE class walks students through a software package to practice both design and analysis. Classes can be tailored specifically to you modified for your needs. Do you have a corporate standard for statistical software (e.g. MiniTab, JMP, Excel…)? Would you like to target R&D, Engineering, Validation, QA, or Regulatory? Would you like students to gather dissolution time data with placebo-product supplied in-house or with inactive samples prepared in our own lyophilizer? etc…With such details a semi-customized course outline can be prepared for your consideration.

  • Statistics for Non-Statisticians »

    3 days
    Introductory statistics. The focus is on basic concepts, not mathematical theory. Numerous videotapes and in-class exercises increase understanding of practical applications. All technical personnel will benefit.

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News & Events

Upcoming Course:
Thursday & Friday– September 28-29, 2017

DoE Basics for Validation by Design for PDA in Berlin, Germany
Learn More

Classes for 2018 being finalized now!


 

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