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Serving Pharmaceutical, Medical Device, and Biotechnology Industries

RCA6430 Statistics for the Life Sciences Industry (1 day)

  

Aims and Objectives

The correct use of statistics is an essential part of any efficient production facility. With more emphasis being placed on activities such as Risk Assessment and Quality by Design by regulatory agencies, companies with a firm grasp of the fundamentals of statistics will be the most successful over the coming years.

Regulatory Compliance Associates Inc. holds one-day workshops in the basic principles of statistics in the pharmaceutical and medical device industries. It is targeted at people who are required to manage and interpret production and control data. It is also relevant to those who are looking for a refresher course on the use and interpretation of statistics.

On completion of this subject students should have an understanding of the concepts and statistical methods required in the production and control of pharmaceuticals and medical devices. They should be able to interpret results related to production and analysis issues.

Content

  • Populations and Samples
  • Descriptive Statistics
    • Sample and Population Mean, Median and Mode
    • Standard Deviation
  • The Normal Distribution and its application to industrial situations
  • Confidence Intervals
  • Hypothesis testing
    • t-tests
    • F-tests
    • Outliers
  • Analysis of Variance (ANOVA)
  • Control Charts and Process Capability
  • An Introduction to Regression Analysis

Format

All topics will be described with relevant practical examples from the pharmaceutical and medical device industries. Copies of all presentation slides and handouts will be provided.